Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding

Phase 3

Completed

• Conditions: Metrorrhagia
• Interventions: Drug: EV/DNG (Qlaira, Natazia, BAY86-5027); Drug: placebo

• Registration Number: NCT01638923
• Lead Sponsor: Bayer

Brief Summary

To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-20
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-12
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-08
• Last Update Posted: 2015-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 339

Inclusion Criteria

• Women 18 years or older in generally good health with a diagnosis of heavy menstrual bleeding without organic pathology, requesting contraception
• Willingness to use barrier contraception (e.g., condoms) from screening to study completion
• Willingness to use and collect sanitary protection (pads and tampons) provided by the sponsor and compatible with the alkaline hematin test throughout study completion

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Exclusion Criteria

• Current diagnosis of organic uterine bleeding
• History of endometrial ablation, or dilatation and curettage within 2 months of Visit 1.
• Clinically significant pelvic findings (whether or not confirmed by transvaginal ultrasound [TVU]).
• Clinically significant abnormal results of breast examination (breast palpation).
• Positive pregnancy test at Visit 1
• Less than three months since delivery, abortion, or lactation before to start Visit 1
• Other contraceptive methods
• Any disease or condition that may worsen under hormonal treatment
• Smokers over the age of 35
• Body mass index >32

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	EV/DNG (Qlaira, Natazia, BAY86-5027)	-
Arm 2	placebo	-

Primary Outcome Measures

Name	Time	Method
Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 days	90 day baseline period and 90 days during treatment period

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with successful treatment	90 days during treatment phase	Successful treatment is defined as no bleeding episode with MBL of 80 mL or more and a decrease to a value \</=50% of MBL compared to 90 day run-in period
Absolute change of average MBL at baseline and up to cycle 7 (one cycle = 28 days)	Baseline and cycle 1, cycle 2, cycle 3, cycle 4, cycle 5, cycle 6, cycle 7
Number of participants with adverse events as a measure of safety and tolerability	Up to 12 months
Percent change of MBL at baseline and 90 day period during treatment phase	Baseline and 90 days during treatment phase
Proportion of subjects with improvement in the investigator's global assessment scale on Day 84	Treatment day 84	Investigator's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
Proportion of subjects with improvement in the investigator's global assessment scale on Day 196	Treatment day 196	Investigator's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
Proportion of subjects with improvement in the subject's global assessment scale on Day 84	Treatment day 84	Subject's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
Proportion of subjects with improvement in the subject's global assessment scale on Day 196	Treatment day 196	Subject's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.