Metrorrhagia
Conditions
Keywords
Heavy Menstrual Bleeding, Efficacy, Safety, Oral contraceptive, Estradiol valerate, Dienogest
Brief summary
To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding
Interventions
DRUGEV/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.
DRUGplacebo
Matching placebo to be taken orally daily for 7 cycles of 28 days each.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 days | 90 day baseline period and 90 days during treatment period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change of MBL at baseline and 90 day period during treatment phase | Baseline and 90 days during treatment phase | — |
| Absolute change of average MBL at baseline and up to cycle 7 (one cycle = 28 days) | 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 | 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 successful treatment | 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 |
| Proportion of subjects with improvement in the subject's global assessment scale on Day 84 | 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 | 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 | Up to 12 months | — |
| Proportion of subjects with improvement in the investigator's global assessment scale on Day 196 | 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. |
Countries
China, Philippines, Russia, Singapore, Taiwan, Thailand
Outcome results
None listed