MetrorrhagiaPhase 3NCT01638923
Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding
A Phase 3 study testing EV/DNG (Qlaira, Natazia, BAY86-5027) in people with Metrorrhagia, run by Bayer at 41 sites in 6 countries.
Trial summary
To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metrorrhagia
- What is being tested?
- EV/DNG (Qlaira, Natazia, BAY86-5027)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 339 participants
- Where
- 41 sitesin 6 countries
- Study dates
- Jun 2012to Jun 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Other contraceptive methods
- Any disease or condition that may worsen under hormonal treatment
- Smokers over the age of 35
- Body mass index >32
Trial locations and contacts
41 sites in 6 countries.
41 sites in 6 countries
China24 sites
Study site
Beijing, 100026
Study site
Beijing, 100034
Study site
Beijing, 100044
Study site
Beijing, 100730
Study site
Changchun
Study site
Changsha, Hunan, 410013
Study site
Chengdu, Sichuan, 610041
Study site
Chengdu, Sichuan, 610072
Study site
Chongqing, 400010
Study site
Dalian, Liaoning, 116011
Study site
Guangzhou, Guangdong, 510120
Study site
Hengyang, Hunan, 421001
Study site
Jinan, Shandong, 250012
Study site
Nanning, Guangxi, 530021
Study site
Qingdao, 266071
Study site
Shanghai, 200030
Study site
Shanghai, 2100129
Study site
Shenyang, Liaoning, 110004
Study site
Shijiazhuang, Hebei, 050051
Study site
Tianjin, 300193
Study site
Tianjin, 300211
Study site
Wuhan, Hubei, 430030
Study site
Wuhan, Hubei, 430032
Study site
Xi'an, Shaanxi, 710032
Russia7 sites
Study site
Irkutsk, 664003
Study site
Ivanovo, 153045
Study site
Krasnodar, 350012
Study site
Moscow, 117049
Study site
Moscow, 117415
Study site
Saint Petersburg, 194354
Study site
Saint Petersburg, 199034
Taiwan4 sites
Study site
Taichung, 40705
Study site
Tainan
Study site
Taipei, 100
Study site
Taipei, 11217
About this study
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
To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding
- Conditions
- Metrorrhagia
- Being tested
- EV/DNG (Qlaira, Natazia, BAY86-5027), placebo
- Keywords
- Heavy Menstrual Bleeding, Efficacy, Safety, Oral contraceptive, Estradiol valerate, Dienogest
- Medical subject headings
- Metrorrhagia, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV/DNG (Qlaira, Natazia, BAY86-5027)Drug
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.
placeboDrug
Matching placebo to be taken orally daily for 7 cycles of 28 days each.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: EV/DNG (Qlaira, Natazia, BAY86-5027) |
| Arm 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 days
Measured: 90 day baseline period and 90 days during treatment period
Secondary outcomes (8)
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
Measured: 90 days during treatment phase
Percent change of MBL at baseline and 90 day period during treatment phase
Measured: Baseline and 90 days during treatment phase
Absolute change of average MBL at baseline and up to cycle 7 (one cycle = 28 days)
Measured: 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
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.
Measured: Treatment day 84
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.
Measured: Treatment day 196
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.
Measured: Treatment day 84
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.
Measured: Treatment day 196
Number of participants with adverse events as a measure of safety and tolerability
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetrorrhagiaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638923
- Sponsor's protocol ID
- 91774
- Other IDs
- X311965
- Status last verified
- Jul 2015
- First submitted
- 20 Jun 2012
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01638923
- Acronym / sponsor ID
- 91774
- Conditions
- Metrorrhagia
- Keywords
- Heavy Menstrual Bleeding, Efficacy, Safety, Oral contraceptive, Estradiol valerate, Dienogest
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: EV/DNG (Qlaira, Natazia, BAY86-5027) |
| Arm 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Arm 1 |
| placeboMatching placebo to be taken orally daily for 7 cycles of 28 days each. | Drug | Arm 2 |
Primary outcome
Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 days
Time frame: 90 day baseline period and 90 days during treatment period
8 secondary outcomes
Proportion of subjects with successful treatment
Time frame: 90 days during treatment phase
Percent change of MBL at baseline and 90 day period during treatment phase
Time frame: Baseline and 90 days during treatment phase
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
Proportion of subjects with improvement in the investigator's global assessment scale on Day 84
Time frame: Treatment day 84
Proportion of subjects with improvement in the investigator's global assessment scale on Day 196
Time frame: Treatment day 196
Proportion of subjects with improvement in the subject's global assessment scale on Day 84
Time frame: Treatment day 84
Proportion of subjects with improvement in the subject's global assessment scale on Day 196
Time frame: Treatment day 196
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
41 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EV/DNG (Qlaira, Natazia, BAY86-5027) in people with Metrorrhagia, run by Bayer at 41 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in China, Russia, Taiwan, Philippines, Singapore and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 days (time frame: 90 day baseline period and 90 days during treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2015.