Trial Condition(s):
Metrorrhagia
Study of a 4-phasic oral contraceptive for the treatment of heavy menstrual bleeding
Bayer Identifier:
91774
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Singapore, Singapore, 229899 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 169608 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ivanovo, Russia, 153045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Krasnodar, Russia, 350012 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Irkutsk, Russia, 664003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 199034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 119415 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bangkok, Thailand, 10700 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bangkok, Thailand, 10330 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Manila, Philippines | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 11217 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tainan, Taiwan, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Quezon City, Philippines | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100730 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jinan, China, 250012 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guangzhou, China, 510120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100044 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shenyang, China, 110004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chongqing, China, 400010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dalian, China, 116011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wuhan, China, 430022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Xi'an, China, 710032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Qingdao, China, 266071 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Changchun, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tianjin, China, 300193 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tianjin, China, 300211 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shijiazhuang, China, 050051 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wuhan, China, 430030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chengdu, China, 610072 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nanning, China, 530021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hengyang, China, 421001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Changsha, China, 410013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taichung, Taiwan, China, 40705 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chengdu, China, 610041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 194354 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 117049 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 daysTimeframe: 90 day baseline period and 90 days during treatment period
Secondary Outcome
- Proportion of subjects with successful treatmentSuccessful 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 periodTimeframe: 90 days during treatment phase
- Percent change of MBL at baseline and 90 day period during treatment phaseTimeframe: Baseline and 90 days during treatment phase
- Absolute change of average MBL at baseline and up to cycle 7 (one cycle = 28 days)Timeframe: 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 84Investigator’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.Timeframe: Treatment day 84
- Proportion of subjects with improvement in the investigator's global assessment scale on Day 196Investigator’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.Timeframe: Treatment day 196
- Proportion of subjects with improvement in the subject's global assessment scale on Day 84Subject’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.Timeframe: Treatment day 84
- Proportion of subjects with improvement in the subject's global assessment scale on Day 196Subject’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.Timeframe: Treatment day 196
- Number of participants with adverse events as a measure of safety and tolerabilityTimeframe: Up to 12 months
Additional Information
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