ContraceptionPhase 3NCT01638910
Efficacy and Safety of a Combined Oral Contraceptive of Estradiol Valerate and Dienogest in Healthy Female Subjects
A Phase 3 study testing EV/DNG (Qlaira, BAY86-5027) in people with Contraception, run by Bayer at 39 sites in 5 countries.
Trial summary
To evaluate the efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in healthy female subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- EV/DNG (Qlaira, BAY86-5027)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 955 participants
- Where
- 39 sitesin 5 countries
- Study dates
- Jun 2012to Nov 2014
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women between 18 and 50 for the entire study, except women enrolled from India should be aged between 18 and 40 years, requesting contraception
- Smokers may not exceed 35 years of age
Who cannot join
- Pregnancy or lactation (delivery, abortion, or lactation within less than three cycles before the start of treatment)
- Body mass index (BMI) > 32 kg/m2
- Any disease or condition that may worsen under hormonal treatment
- Undiagnosed abnormal genital bleeding
- Other contraceptive methods such as sterilization, hormonal contraception, IUD within 30 days of Visit 1, monthly contraceptive injection within a period of three times of the injection interval before start of treatment
- Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results
Trial locations and contacts
39 sites in 5 countries.
39 sites in 5 countries
China23 sites
Study site
Beijing, 100044
Study site
Beijing, 100730
Study site
Changsha, Hunan, 410013
Study site
Chengdu, Sichuan, 610041
Study site
Chongqing, 400016
Study site
Chongqing, 400038
Study site
Chongqing, 400042
Study site
Dalian, Liaoning, 116011
Study site
Guangzhou, Guangdong, 510120
Study site
Guangzhou, Guangdong, 510405
Study site
Hengyang, Hunan, 421001
Study site
Jinan, Shandong, 250012
Study site
Nanjing, Jiangsu, 210009
Study site
Shanghai, 200025
Study site
Shanghai, 200030
Study site
Shanghai, 200127
Study site
Shanghai, 2100129
Study site
Shenyang, Liaoning, 110004
Study site
Shijiazhuang, Hebei, 050051
Study site
Tianjin, 300211
Study site
Wenzhou, Zhejiang, 325027
Study site
Wuhan, Hubei, 430030
Study site
Wuhan, Hubei, 430032
India6 sites
Study site
Chandigarh
Study site
Karnāl, 132001
Study site
New Delhi, 110 029
Study site
Pune, Maharashtra, 411001
Study site
Pune, 411004
Study site
Secunderabad, 500003
Taiwan6 sites
Study site
Kaohsiung City, 80756
Study site
Taichung, 40705
Study site
Taipei, Taipei, 116
Study site
Taipei, 100
Study site
Taipei, 11217
Study site
Taoyuan, 333
Thailand3 sites
Study site
Bangkok, Thailand, 10330
Study site
Bangkok, 10700
Study site
Chiang Mai, 50200
About this study
Official title: A Multi-center, Open, Uncontrolled Phase 3 Study to Investigate the Efficacy and Safety of a 4-phasic Oral Contraceptive SH T00658ID Containing Estradiol Valerate and Dienogest in a 28-day Regimen for 13 Cycles in Healthy Female Subjects
To evaluate the efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in healthy female subjects.
- Conditions
- Contraception
- Being tested
- EV/DNG (Qlaira, BAY86-5027)
- Keywords
- Efficacy, Safety, oral contraception, estradiol valerate, dienogest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV/DNG (Qlaira, BAY86-5027)Drug
Oral estradiol valerate and dienogest (2 days 3.0 mg estradiol valerate (EV), 5 days 2.0 mg EV + 2.0 mg dienogest (DNG), 17 days 2.0 mg EV + 3.0 mg DNG, 2 days 1.0 mg EV, 2 days placebo), one table oral daily for 13 treatment cycles (1 cycle = 28days)
| Study group | Role | What they receive |
|---|---|---|
| EV/DNG (Qlaira, BAY86-5027) | Experimental | Not described Receives: Drug: EV/DNG (Qlaira, BAY86-5027) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of unintended pregnancies
Measured: Up to Cycle 13 (1 Cycle = 28 days)
Secondary outcomes (5)
Number of expected bleeding days
Measured: Up to Cycle 13 (1 Cycle = 28 days)
Number of unexpected bleeding days
Measured: Up to Cycle 13 (1 Cycle = 28 days)
Number of expected bleeding episodes
Measured: Up to Cycle 13 (1 Cycle = 28 days)
Number of unexpected bleeding episodes
Measured: Up to Cycle 13 (1 Cycle = 28 days)
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Up to Cycle 13 (1 Cycle = 28 days)
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 completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 955 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
- NCT01638910
- Sponsor's protocol ID
- 91773
- Status last verified
- Dec 2014
- First submitted
- 20 Jun 2012
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Yu Q, Huang Z, Ren M, Chang Q, Zhang Z, Parke S. Contraceptive efficacy and safety of estradiol valerate/dienogest in a healthy female population: a multicenter, open-label, uncontrolled Phase III study. Int J Womens Health. 2018 Jun 7;10:257-266. doi: 10.2147/IJWH.S157056. eCollection 2018.
PubMed 29922096
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open, Uncontrolled Phase 3 Study to Investigate the Efficacy and Safety of a 4-phasic Oral Contraceptive SH T00658ID Containing Estradiol Valerate and Dienogest in a 28-day Regimen for 13 Cycles in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT01638910
- Acronym / sponsor ID
- 91773
- Conditions
- Contraception
- Keywords
- Efficacy, Safety, oral contraception, estradiol valerate, dienogest
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 955 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (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 the efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in healthy female subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EV/DNG (Qlaira, BAY86-5027) | Experimental | Drug: EV/DNG (Qlaira, BAY86-5027) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy women between 18 and 50 for the entire study, except women enrolled from India should be aged between 18 and 40 years, requesting contraception
- Smokers may not exceed 35 years of age
Key exclusion criteria (6 listed)
- Pregnancy or lactation (delivery, abortion, or lactation within less than three cycles before the start of treatment)
- Body mass index (BMI) > 32 kg/m2
- Any disease or condition that may worsen under hormonal treatment
- Undiagnosed abnormal genital bleeding
- Other contraceptive methods such as sterilization, hormonal contraception, IUD within 30 days of Visit 1, monthly contraceptive injection within a period of three times of the injection interval before start of treatment
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, BAY86-5027)Oral estradiol valerate and dienogest (2 days 3.0 mg estradiol valerate (EV), 5 days 2.0 mg EV + 2.0 mg dienogest (DNG), 17 days 2.0 mg EV + 3.0 mg DNG, 2 days 1.0 mg EV, 2 days placebo), one table oral daily for 13 treatment cycles (1 cycle = 28days) | Drug | EV/DNG (Qlaira, BAY86-5027) |
Primary outcome
Number of unintended pregnancies
Time frame: Up to Cycle 13 (1 Cycle = 28 days)
5 secondary outcomes
Number of expected bleeding days
Time frame: Up to Cycle 13 (1 Cycle = 28 days)
Number of unexpected bleeding days
Time frame: Up to Cycle 13 (1 Cycle = 28 days)
Number of expected bleeding episodes
Time frame: Up to Cycle 13 (1 Cycle = 28 days)
Number of unexpected bleeding episodes
Time frame: Up to Cycle 13 (1 Cycle = 28 days)
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to Cycle 13 (1 Cycle = 28 days)
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 17 Dec 2014.
- Derived from this study: PubMed 29922096Yu Q, Huang Z, Ren M, Chang Q, Zhang Z, Parke S. Contraceptive efficacy and safety of estradiol valerate/dienogest in a healthy female population: a multicenter, open-label, uncontrolled Phase III study. Int J Womens Health. 2018 Jun 7;10:257-266. doi: 10.2147/IJWH.S157056. eCollection 2018.
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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
39 sites in 5 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, BAY86-5027) in people with Contraception, run by Bayer at 39 sites in 5 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 2 inclusion and 6 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 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in China, India, Taiwan, Thailand, Hong Kong. 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. 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?
Number of unintended pregnancies (time frame: Up to Cycle 13 (1 Cycle = 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01638910, which also lists 1 linked publication.
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 17 Dec 2014.