Ovulation InhibitionPhase 2NCT00805415
Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens
A Phase 2 study testing EV/DNG (Qlaira, BAY86-5027, SH T00658K) and EV/DNG (SH T00658L) in people with Ovulation Inhibition, run by Bayer at 2 sites in 2 countries.
Trial summary
The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral contraceptive regimens. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovulation Inhibition
- What is being tested?
- EV/DNG (Qlaira, BAY86-5027, SH T00658K) and EV/DNG (SH T00658L)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2003to Feb 2004
- Phase
- Phase 2
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women willing to use non-hormonal methods of contraception
Who cannot join
- Women with any contraindication for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thrombembolic events, hypertension, presence or history of severe hepatic disease
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Multicenter, Open-label, Randomized, Comparative Study to Evaluate Ovulation Inhibition With Two 4-phasic Oral Contraceptive Regimens Containing Estradiol Valerate and Dienogest Applied Daily for Three Cycles to 200 Healthy Female Volunteer
The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral contraceptive regimens.
- Conditions
- Ovulation Inhibition
- Being tested
- EV/DNG (Qlaira, BAY86-5027, SH T00658K), EV/DNG (SH T00658L)
- Keywords
- Oral Contraceptive, Ovulation Inhibition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV/DNG (Qlaira, BAY86-5027, SH T00658K)Drug
Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 2 and 3 mg
EV/DNG (SH T00658L)Drug
Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 3 and 4 mg
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K) |
| Arm 2 | Experimental | Not described Receives: Drug: EV/DNG (SH T00658L) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation)
Measured: Treatment cycles 2 and 3
Secondary outcomes (8)
Proportion of subjects with a Hoogland score of 5-6 (LUF or ovulation)
Measured: Treatment cycles 2 or 3
Measurements of endometrial thickness
Measured: Treatment cycles 2 and 3
Visibility of cervical mucus
Measured: Treatment cycles 2 and 3
Ovarian activity (Hoogland score)
Measured: Posttreatment cycle (only subjects from center 2)Treatment cycles 2 and 3
Measurements of follicle size
Measured: Treatment cycles 2 and 3
Measurements of hormone levels (follicle-stimulating hormone [FSH], luteinizing hormone [LH], progesterone and estradiol)
Measured: Treatment cycles 2 and 3
Compliance
Measured: Throughout whole study
Medical, surgical and medication history, concomitant medication, general physical and gynecological examination, cervical smear, pregnancy test, adverse events, safety laboratory determinations, cycle control, vital signs
Measured: Various timepoint throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startMar 2003
- Primary completionFeb 2004
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovulation InhibitionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805415
- Sponsor's protocol ID
- 91271
- Other IDs
- 307300
- Status last verified
- Jul 2011
- First submitted
- 8 Dec 2008
- Last updated
- 15 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label, Randomized, Comparative Study to Evaluate Ovulation Inhibition With Two 4-phasic Oral Contraceptive Regimens Containing Estradiol Valerate and Dienogest Applied Daily for Three Cycles to 200 Healthy Female Volunteer
- ClinicalTrials.gov ID
- NCT00805415
- Acronym / sponsor ID
- 91271
- Conditions
- Ovulation Inhibition
- Keywords
- Oral Contraceptive, Ovulation Inhibition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 9 Dec 2008 (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.
The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral contraceptive regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K) |
| Arm 2 | Experimental | Drug: EV/DNG (SH T00658L) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy women willing to use non-hormonal methods of contraception
Key exclusion criteria (1 listed)
- Women with any contraindication for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thrombembolic events, hypertension, presence or history of severe hepatic disease
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, SH T00658K)Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 2 and 3 mg | Drug | Arm 1 |
| EV/DNG (SH T00658L)Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 3 and 4 mg | Drug | Arm 2 |
Primary outcome
Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation)
Time frame: Treatment cycles 2 and 3
8 secondary outcomes
Proportion of subjects with a Hoogland score of 5-6 (LUF or ovulation)
Time frame: Treatment cycles 2 or 3
Measurements of endometrial thickness
Time frame: Treatment cycles 2 and 3
Visibility of cervical mucus
Time frame: Treatment cycles 2 and 3
Ovarian activity (Hoogland score)
Time frame: Posttreatment cycle (only subjects from center 2)Treatment cycles 2 and 3
Measurements of follicle size
Time frame: Treatment cycles 2 and 3
Measurements of hormone levels (follicle-stimulating hormone [FSH], luteinizing hormone [LH], progesterone and estradiol)
Time frame: Treatment cycles 2 and 3
Compliance
Time frame: Throughout whole study
Medical, surgical and medication history, concomitant medication, general physical and gynecological examination, cervical smear, pregnancy test, adverse events, safety laboratory determinations, cycle control, vital signs
Time frame: Various timepoint throughout the study
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 15 Jul 2011.
Related trials for Ovulation Inhibition
RecruitingPhase 2
Investigating Ovulation Inhibition for Use as a Contraceptive
Contraception
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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EV/DNG (Qlaira, BAY86-5027, SH T00658K) and EV/DNG (SH T00658L) in people with Ovulation Inhibition, run by Bayer at 2 sites in 2 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 1 inclusion and 1 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 15 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation) (time frame: Treatment cycles 2 and 3). 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 15 Jul 2011.