Effects of SH T00658ID on Libido

Phase 3

Completed

• Conditions: Libido; Contraception
• Interventions: Drug: Microgynon; Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID); Drug: Placebo

• Registration Number: NCT00764881
• Lead Sponsor: Bayer

Brief Summary

The aim of the study is to investigate whether women on oral contraceptives (OCs) suffering from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year will express the same level of sexual distress when taking SH T00658ID compared to Microgynon, the usual OC prescribed for women with OC-associated FSD.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-10-01
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Study Start: 2009-01
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2011-07-28
• Results First Submitted QC: 2012-03-06
• Results First Posted: 2012-04-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 217

Inclusion Criteria

• OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year and willingness to continue OC use but to switch to SH T00658ID or Microgynon
• Combined score of the sexual desire and arousal domains of the FSFI questionnaire of 18 or below at screening and baseline

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Exclusion Criteria

• Contraindications for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thromboembolic events, hypertension, presence or history of severe hepatic disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EE/LNG (Microgynon) + Placebo	Placebo	Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
EE/LNG (Microgynon) + Placebo	Microgynon	Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EV/DNG (Qlaira, BAY86-5027, SH T00658ID)	Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Full Analysis Set (FAS)	Baseline up to Cycle 6 (28 days per Cycle)	Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).
Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Per Protocol Set (PPS)	Baseline up to Cycle 6 (28 days per Cycle)	Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).

Secondary Outcome Measures

Name	Time	Method
Number of Bleeding / Spotting Days in Reference Period 2	From Day 91 to Day 180	Reference Period 2 is defined as Day 91 to 180 during study treatment
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score	Baseline up to Cycle 6 (28 days per Cycle)	Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the QLES-Q (short version - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Baseline	At Baseline	Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6	At Cycle 6 (28 days per Cycle)	Sum of questions 3 to 6 on sexual arousal on FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).
The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6	At Cycle 6 (28 days per Cycle)	Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).
The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6	At Cycle 6 (28 days per Cycle)	Sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).
The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6	At Cycle 6 (28 days per Cycle)	Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score	Baseline up to Cycle 6 (28 days per Cycle)	Change from Baseline to Cycle 6 in the PGWBI Questionnaire's assessment of the participant's overall sense of well-being or distress. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score ranges from -100 (worst) to 100 (best).
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Baseline	At Baseline	Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline	At Baseline	Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)	Baseline up to Cycle 6 (28 days per Cycle)	Mean change from Baseline to Cycle 6 in the sum of questions 11 to 13 on orgasm on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).
The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline	At Baseline	Sum of Questions 14 to 16 on satisfaction on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)	Baseline up to Cycle 6 (28 days per Cycle)	Mean change from Baseline to Cycle 6 in the sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -5.2 (worst) to 5.2 (best).
The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline	At Baseline	Sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)	Baseline up to Cycle 6 (28 days per Cycle)	Mean change from Baseline to Cycle 6 in the sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).
The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline	At Baseline	Sum of questions 11 to 13 on orgasm on FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).
The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6	At Cycle 6 (28 days per Cycle)	Sum of questions 11 to 13 on orgasm on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).
The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6	At Cycle 6 (28 days per Cycle)	Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)	Baseline up to Cycle 6 (28 days per Cycle)	Mean change from Baseline to Cycle 6 in the sum of questions 17 to 19 on pain on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).
The Mean Absolute Values of FSFI Total Score at Cycle 6	At Cycle 6 (28 days per Cycle)	The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).
The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline	At Baseline	Q-LES-Q (short version - 16 items) assessed at Baseline the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).
The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline	At Baseline	Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Baseline. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)	Baseline up to Cycle 6 (28 days per Cycle)	Mean change from Baseline to Cycle 6 in the sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire. The change in the normalized score for those 2 questions ranges from -4.8 (worst) to 4.8 (best).
The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.	At Baseline	Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).
The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline	At Baseline	Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Baseline	At Baseline	Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Baseline	At Baseline	Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)	Baseline up to Cycle 6 (28 days per Cycle)	Mean change from Baseline at Cycle 6 in the sum of questions 7 to 10 on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).
The Mean Absolute Values of FSFI Total Score at Baseline	At Baseline	The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).
The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6	At Cycle 6 (28 days per Cycle)	Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Cycle 6. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).
Mean Change From Baseline to Cycle 6 in FSFI Total Score	Baseline up to Cycle 6 (28 days per Cycle)	The change in the normalized FSFI total score ranges from -34 (worst) to 34 (best).
Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score	Baseline up to Cycle 6 (28 days per Cycle)	Change from Baseline to Cycle 6 in the validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The change in total score ranges from -52 (best) to 52 (worst).
The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6	At Cycle 6 (28 days per Cycle)	Q-LES-Q (short version - 16 items) assessed at Cycle 6 the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Cycle 6	At Cycle 6 (28 days per Cycle)	Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Cycle 6	At Cycle 6 (28 days per Cycle)	Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Cycle 6	At Cycle 6 (28 days per Cycle)	General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Baseline	At Baseline	Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Self-control	Baseline up to Cycle 6 (28 days per Cycle)	Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - self-control score ranges from -100 (worst) to 100 (best).
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Baseline	At Baseline	General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - General Health	Baseline up to Cycle 6 (28 days per Cycle)	General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale the change in the normalized PGWBI general health score ranges from -100 (worst) to 100 (best).
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline	At Baseline	The PGWBI measured at Baseline self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6	At Cycle 6 (28 days per Cycle)	The PGWBI measured at Cycle 6 self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Anxiety	Baseline up to Cycle 6 (28 days per Cycle)	Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - Anxiety score ranges from -100 (worst) to 100 (best).
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Cycle 6	At Cycle 6 (28 days per Cycle)	Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Depressed Mood	Baseline up to Cycle 6 (28 days per Cycle)	Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - depressed mood score ranges from -100 (worst) to 100 (best).
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Cycle 6	At Cycle 6 (28 days per Cycle)	Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Positive Well-being	Baseline up to Cycle 6 (28 days per Cycle)	Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - positive well-being score ranges from -100 (worst) to 100 (best).
Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline	At Baseline	ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).
Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)	Baseline up to Cycle 6 (28 days per Cycle)	ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe). The change in average score ranges from -3 (best) to 3 (worst).
Number of Bleeding / Spotting Episodes in Reference Period 1	From Day 1 to Day 90	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the fist treatment cycle includes 2 bleeding episodes
Number of Spotting Only Days in Reference Period 2	From Day 91 to Day 180	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Mean Length of Spotting-only Episodes in Reference Period 2	From Day 91 to Day 180	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1	From Day 1 to Day 90	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6	At Cycle 6 (28 days per Cycle)	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1	At Cycle 1 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Cycle 6	At Cycle 6 (28 days per Cycle)	Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6	At Cycle 6 (28 days per Cycle)	In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.
Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6	At Cycle 6 (28 days per Cycle)	The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH\<4) to 3 (severe or pH5).
Number of Bleeding / Spotting Days in Reference Period 1	From Day 1 to Day 90	Reference Period 1 is defined as Day 1 to 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Number of Bleeding / Spotting Episodes in Reference Period 2	From Day 91 to Day 180	Reference Period 2 is defined as Day 91 to Day 180 during study treatment
Mean Length of Bleeding / Spotting Episodes in Reference Period 2	From Day 91 to Day 180	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Maximum Length of Bleeding / Spotting Episodes in Reference Period 1	From Day 1 to Day 90	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Number of Spotting Only Episodes in Reference Period 1	From Day 1 to Day 90	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Number of Spotting Only Episodes in Reference Period 2	From Day 91 to Day 180	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2	From Day 91 to Day 180	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1	At Cycle 1 (28 days per Cycle)	Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Vitality	Baseline up to Cycle 6 (28 days per Cycle)	Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - vitality score ranges from -100 (worst) to 100 (best).
Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6	At Cycle 6 (28 days per Cycle)	CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.
Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline	At Baseline	The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH\<4) to 3 (severe or pH5).
Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA)	Baseline up to Cycle 6 (28 days per Cycle)	The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH\<4) to 3 (severe or pH5). The change in average score ranges from -3 (best) to 3 (worst).
Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1	From Day 1 to Day 90	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2	From Day 91 to Day 180	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Number of Spotting Only Days in Reference Period 1	From Day 1 to Day 90	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Length of Withdrawal Bleeding Episodes at Cycle 3	At Cycle 3 (28 days per Cycle)	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1	At Cycle 1 (28 days per Cycle)	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.
Vaginal Effects Evaluated by Vaginal pH at Cycle 6	At Cycle 6 (28 days per Cycle)	Vaginal pH (0 to 6) measured by subject using a pH indicator dipstick
Mean Length of Bleeding / Spotting Episodes in Reference Period 1	From Day 1 to Day 90	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes
Maximum Length of Bleeding / Spotting Episodes in Reference Period 2	From Day 91 to Day 180	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Mean Length of Spotting-only Episodes in Reference Period 1	From Day 1 to Day 90	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Maximum Length of Spotting-only Episodes in Reference Period 1	From Day 1 to Day 90	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Maximum Length of Spotting-only Episodes in Reference Period 2	From Day 91 to Day 180	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Length of Withdrawal Bleeding Episodes at Cycle 1	At Cycle 1 (28 days per Cycle)	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3	At Cycle 3 (28 days per Cycle)	Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6	At Cycle 6 (28 days per Cycle)	Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.
Maximum Length of Intracyclic Bleeding Episodes at Cycle 1	At Cycle 1 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6	At Cycle 6 (28 days per Cycle)	ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1	At Cycle 1 (28 days per Cycle)	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3	At Cycle 3 (28 days per Cycle)	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end
Length of Withdrawal Bleeding Episodes at Cycle 6	At Cycle 6 (28 days per Cycle)	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6	At Cycle 6 (28 days per Cycle)	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.
Onset of Withdrawal Bleeding Episodes at Cycle 3	From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3	Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.
Onset of Withdrawal Bleeding Episodes at Cycle 6	From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6	Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.
Number of Intracyclic Bleeding Days at Cycle 6	At Cycle 6 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Percentage of Participants With at Least 1 Intracyclic Bleeding Episode	Up to Cycle 6 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3	At Cycle 3 (28 days per Cycle)	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.
Onset of Withdrawal Bleeding Episodes at Cycle 1	From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1	Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3	At Cycle 3 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Number of Intracyclic Bleeding Episodes at Cycle 6	At Cycle 6 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Maximum Length of Intracyclic Bleeding Episodes at Cycle 3	At Cycle 3 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Number of Intracyclic Bleeding Days at Cycle 1	At Cycle 1 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Number of Intracyclic Bleeding Days at Cycle 3	At Cycle 3 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6	At Cycle 6 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Number of Intracyclic Bleeding Episodes at Cycle 1	At Cycle 1 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Number of Intracyclic Bleeding Episodes at Cycle 3	At Cycle 3 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Maximum Length of Intracyclic Bleeding Episodes at Cycle 6	At Cycle 6 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1	At Cycle 1 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3	At Cycle 3 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6	At Cycle 6 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.

Trial Locations

Locations (32)

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Clin Pharm International GmbH Studienzentrum Wien; 🇦🇹 Wien, Austria

Sydney Centre for Reproductive Health Reseach; 🇦🇺 Ashfield, New South Wales, Australia

Royal Hospital for Women; 🇦🇺 Sydney, New South Wales, Australia

The Alfred Hospital; 🇦🇺 Prahran, Victoria, Australia

King Edward Memorial Hospital; 🇦🇺 Subiaco, Western Australia, Australia

Queen Elizabeth II Medical Centre; 🇦🇺 Nedlands, Western Australia, Australia

Ordination Dr.Hohlweg; 🇦🇹 Graz, Steiermark, Austria

Ordination Dr. Schmidl-Amann; 🇦🇹 St. Pölten, Niederösterreich, Austria

Ordination Dr. Schaffer; 🇦🇹 Graz, Steiermark, Austria

Dr. Brigitte Wiesenthal; 🇦🇹 Wien, Austria

Dr. Wolfgang Bartl; 🇦🇹 Wien, Austria

Dr. Walter Paulik; 🇦🇹 Zeltweg, Austria

Hôpital Erasme/Erasmus Ziekenhuis; 🇧🇪 Bruxelles - Brussel, Belgium

UZ Gent; 🇧🇪 Gent, Belgium

UZ Leuven Gasthuisberg; 🇧🇪 Leuven, Belgium

Frauenarztpraxis Dr. Bernd Pittner; 🇩🇪 Leipzig, Sachsen, Germany

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Baden-Württemberg, Germany

Universitätsklinikum Aachen; 🇩🇪 Aachen, Nordrhein-Westfalen, Germany

A.O.U. Policlinico - Vittorio Emanuele; 🇮🇹 Catania, Italy

Praxis Dr. A. Schwenkhagen-Stodieck; 🇩🇪 Hamburg, Germany

A.O.U. di Cagliari; 🇮🇹 Monserrato, Cagliari, Italy

IRCCS Fondazione Maugeri - Montescano (Pavia); 🇮🇹 Pavia, Italy

A.O.U. Pisana; 🇮🇹 Pisa, Italy

Diatros Gava- Centre Assistencial Ntra. Sra. de Burgues; 🇪🇸 Gava, Barcelona, Spain

Centro de Planificacion Familiar Alicante 3; 🇪🇸 Alicante, Spain

USP Institut Universitari Dexeus; 🇪🇸 Barcelona, Spain

Instituto Palacios de Salud y Medicina de la Mujer; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Chulalongkorn Hospital; 🇹🇭 Bangkok, Thailand

Ramathibodhi Hospital; 🇹🇭 Bangkok, Thailand

Siriraj Hospital, Mahidol; 🇹🇭 Bangkok, Thailand