Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT).

Phase 3

Completed

• Conditions: Menopause
• Interventions: Drug: LNG IUS

• Registration Number: NCT00185458
• Lead Sponsor: Bayer

Brief Summary

The study has been designed to look at the transfer from using LNG IUS for contraception only, in reproductive age to using it for endometrial protection in menopausal age. The main area of interest in the study is the pattern of any vaginal bleeding that occurs.

Detailed Description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Study Timeline

• Study Start: 2000-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2009-07-23
• Results First Submitted QC: 2009-10-12
• Results First Posted: 2009-11-19
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-05
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 394

Inclusion Criteria

• Women with intact uterus, regular menstrual cycles and no previous or current climacteric symptoms.

Read More

Exclusion Criteria

• Pregnancy or lactation.
• Previous pelvic infections.
• Abnormal bleeding.
• Abnormal uterine cavity.
• Uterine polyps.
• Genital cancer.
• Liver diseases.
• Alcoholism or drug abuse.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LNG IUS	LNG IUS	Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.

Primary Outcome Measures

Name	Time	Method
Number of Bleeding Days	Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase	Measured by using Subject Diaries (Subject Reported Data)
Number of Spotting Days	Last 90 days in Contraception Phase and first 360 days in HRT Phase	Measured by using Subject Diaries (Subject Reported Data)
Percentage of Participants With Successful Treatment	Last 90 days in Contraception Phase and first 360 days in HRT Phase	Definition of successful treatment: * Completion of HRT phase, and; * Both, the number of bleeding days and the number of spotting days during HRT was equal to or less than during contraceptive phase, and; * The number of bleeding days and the number of spotting days could be calculated for at least 3 out of the first 4 reference periods in HRT

Secondary Outcome Measures

Name	Time	Method
Progestogenic Symptom 6: Decreased Libido (as Measured by a VAS)	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Climacteric Symptom 1: Hot Flushes (as Measured by a VAS)	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Climacteric Symptom 5: Irritability (as Measured by a VAS)	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Climacteric Symptom 6: Breast Tension (as Measured by a VAS)	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Progestogenic Symptom 7: Hair Loss (as Measured by a VAS)	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Progestogenic Symptom 8: Greasy Hair (as Measured by a VAS)	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Progestogenic Symptom 1: Headache (as Measured by a Visual Analogue Scale (VAS))	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Assessment of QOL as Measured by Women's Health Questionnaire	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	Women's Health Questionnaire (Total Score). For the Total score, the minimum is 36 and maximum is 144. A higher score means the distress and dysfunction are less pronounced.
Continuation Rates	At entry, at 2 years, at 4 years	Percentage of subjects continuing in the study at the given time points.
Progestogenic Symptom 2: Depressive Mood (as Measured by a VAS)	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Progestogenic Symptom 3: Acne or Greasy Skin (as Measured by a VAS)	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Progestogenic Symptom 4: Nausea (as Measured by a VAS)	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Progestogenic Symptom 5: Edema (as Measured by a VAS)	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Climacteric Symptom 2: Sweating Episodes (as Measured by a VAS)	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Climacteric Symptom 3: Vaginal Dryness (as Measured by a VAS)	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Climacteric Symptom 4: Sleep Problems (as Measured by a VAS)	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.