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

Bayer339 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

339

Conditions

Metrorrhagia

Interventions

EV/DNG (Qlaira, Natazia, BAY86-5027)DRUG

2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placebo. A blister card consists of 28 pills, taken orally once a day for 7 cycles of 28 days each.

placeboDRUG

Matching placebo to be taken orally daily for 7 cycles of 28 days each.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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 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

Locations (41)

Unnamed facility

Outcomes

Primary Outcomes

Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 days

Time frame: 90 day baseline period and 90 days during treatment period

Secondary Outcomes

Proportion of subjects with successful treatment

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

Time frame: 90 days during treatment phase

Percent change of MBL at baseline and 90 day period during treatment phase

Time frame: Baseline and 90 days during treatment phase

Absolute change of average MBL at baseline and up to cycle 7 (one cycle = 28 days)

Time frame: Baseline and cycle 1, cycle 2, cycle 3, cycle 4, cycle 5, cycle 6, cycle 7

Proportion of subjects with improvement in the investigator's global assessment scale on 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.

Time frame: Treatment day 84

Proportion of subjects with improvement in the investigator's global assessment scale on Day 196

Time frame: Treatment day 196

Proportion of subjects with improvement in the subject's global assessment scale on Day 84

Data from ClinicalTrials.gov

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