check_circleStudy Completed

Metrorrhagia

Bayer Identifier:

91774

ClinicalTrials.gov Identifier:

NCT01638923

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study of a 4-phasic oral contraceptive for the treatment of heavy menstrual bleeding

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • - 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


  • - 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

Trial summary

Enrollment Goal
339
Trial Dates
June 2012 - June 2015
Phase
Phase 3
Could I Receive a placebo
No
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Singapore, 229899, Singapore
Terminated
Singapore, 169608, Singapore
Completed
Ivanovo, 153045, Russia
Completed
Krasnodar, 350012, Russia
Completed
Irkutsk, 664003, Russia
Completed
St. Petersburg, 199034, Russia
Terminated
Moscow, 119415, Russia
Completed
Bangkok, 10700, Thailand
Completed
Bangkok, 10330, Thailand
Completed
Manila, Philippines
Completed
Taipei, 100, Taiwan
Terminated
Taipei, 11217, Taiwan
Completed
Tainan, Taiwan
Completed
Quezon City, Philippines
Completed
Beijing, 100730, China
Completed
Shanghai, 200090, China
Completed
Beijing, 100730, China
Completed
Jinan, 250012, China
Completed
Guangzhou, 510120, China
Completed
Beijing, 100034, China
Completed
Beijing, 100044, China
Completed
Shenyang, 110004, China
Completed
Chongqing, 400010, China
Completed
Dalian, 116011, China
Completed
Shanghai, 200030, China
Completed
Wuhan, 430022, China
Completed
Xi'an, 710032, China
Terminated
Qingdao, 266071, China
Completed
Changchun, China
Completed
Tianjin, 300193, China
Completed
Tianjin, 300211, China
Completed
Shijiazhuang, 050051, China
Completed
Wuhan, 430030, China
Completed
Chengdu, 610072, China
Completed
Nanning, 530021, China
Completed
Beijing, 100026, China
Completed
Hengyang, 421001, China
Completed
Changsha, 410013, China
Completed
Taichung, 40705, Taiwan
Completed
Chengdu, 610041, China
Terminated
St. Petersburg, 194354, Russia
Completed
Moscow, 117049, Russia

Primary Outcome

  • Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 days
    date_rangeTime Frame:
    90 day baseline period and 90 days during treatment period
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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
    date_rangeTime Frame:
    90 days during treatment phase
    enhanced_encryption
    Safety Issue:
    No
  • Percent change of MBL at baseline and 90 day period during treatment phase
    date_rangeTime Frame:
    Baseline and 90 days during treatment phase
    enhanced_encryption
    Safety Issue:
    No
  • Absolute change of average MBL at baseline and up to cycle 7 (one cycle = 28 days)
    date_rangeTime Frame:
    Baseline and cycle 1, cycle 2, cycle 3, cycle 4, cycle 5, cycle 6, cycle 7
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of subjects with improvement in the investigator's global assessment scale on 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.
    date_rangeTime Frame:
    Treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of subjects with improvement in the subject's global assessment scale on 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.
    date_rangeTime Frame:
    Treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of subjects with improvement in the subject's global assessment scale on 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.
    date_rangeTime Frame:
    Treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.