Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding
This study is currently recruiting participants.
Verified May 2013 by Bayer
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01638923
First received: June 20, 2012
Last updated: May 10, 2013
Last verified: May 2013
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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:
MedlinePlus related topics:
Menstruation
Drug Information available for:
Estradiol
Estradiol cypionate
Estradiol valerate
Estradiol acetate
Estradiol hemihydrate
Dienogest
U.S. FDA Resources
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 2014 |
| Estimated Primary Completion Date: | August 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01638923
Show 39 Study Locations
Contacts
| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
Show 39 Study LocationsSponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT01638923 History of Changes |
| Other Study ID Numbers: | 91774, X311965 |
| Study First Received: | June 20, 2012 |
| Last Updated: | May 10, 2013 |
| 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 Hemorrhage Menorrhagia Metrorrhagia Pathologic Processes Uterine Hemorrhage Uterine Diseases Genital Diseases, Female Contraceptive Agents Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Dienogest Contraceptives, Oral |
Estradiol Polyestradiol phosphate Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive Agents, Male |
ClinicalTrials.gov processed this record on May 19, 2013