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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01638923
First received: June 20, 2012
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Metrorrhagia
Drug: EV/DNG (Qlaira, Natazia, BAY86-5027)
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with successful treatment [ Time Frame: 90 days during treatment phase ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of subjects with improvement in the investigator's global assessment scale on Day 84 [ Time Frame: Treatment day 84 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 312
Study Start Date: June 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 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.
Placebo Comparator: Arm 2 Drug: placebo
Matching placebo to be taken orally daily for 7 cycles of 28 days each.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01638923

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

  Show 41 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01638923     History of Changes
Other Study ID Numbers: 91774, X311965
Study First Received: June 20, 2012
Last Updated: August 28, 2014
Health Authority: China: Food and Drug Administration
Philippines: Philippines Food and Drug Administration
Russia: Ministry of Health of the Russian Federation
Thailand: Food and Drug Administration
Taiwan : Food and Drug Administration

Keywords provided by Bayer:
Heavy Menstrual Bleeding
Efficacy
Safety
Oral contraceptive
Estradiol valerate
Dienogest

Additional relevant MeSH terms:
Menstruation Disturbances
Menorrhagia
Metrorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Hemorrhage
Estradiol
Polyestradiol phosphate
Dienogest
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Contraceptive Agents
Contraceptives, Oral
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptive Agents, Male
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014