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

Overview

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

Full Title of Study: “A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled, 7 Cycle Duration (196 Days), Phase 3 Study to Investigate the Efficacy and Safety of Oral Estradiol Valerate / Dienogest Tablets for the Treatment of Heavy Menstrual Bleeding”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2015

Interventions

  • Drug: EV/DNG (Qlaira, Natazia, BAY86-5027)
    • 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.
  • Drug: placebo
    • Matching placebo to be taken orally daily for 7 cycles of 28 days each.

Arms, Groups and Cohorts

  • Experimental: Arm 1
  • Placebo Comparator: Arm 2

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Proportion of subjects with successful treatment
    • Time Frame: 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
  • 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.
  • Number of participants with adverse events as a measure of safety and tolerability
    • Time Frame: Up to 12 months

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

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