ContraceptionPhase 2NCT02550977
Russia/Ukraine Suppression of Ovarian Activity Study
A Phase 2 study testing Gestodene/EE Patch (BAY86-5016) in people with Contraception, run by Bayer at 8 sites in 2 countries.
Trial summary
The purpose of this study is to look into the effectiveness of a new investigational medication applied as a transdermal patch. The patch is applied on the skin with study medication that is absorbed through the skin suppressing ovarian activity and therefore preventing an egg from leaving an ovary (ovulation). 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
- Contraception
- What is being tested?
- Gestodene/EE Patch (BAY86-5016)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 18 Sep 2015to 15 Aug 2016
- 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 female subjects requesting contraception
- Aged 18 to 35 years (inclusive); smokers must not be older than 30 years
- Normal or clinically insignificant cervical smear not requiring further follow-up
- History of regular cyclic menstrual periods
- Willingness to use nonhormonal methods of contraception during the entire study
- Proven ovulation upon completion of the pretreatment cycle
Who cannot join
- Pregnancy or lactation
- Obesity (body mass index [BMI] > 30.0 kg/m2)
- Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape
- Any disease or condition that may worsen under hormonal treatment
- Use of hormonal contraception other than study medication during the study
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Russia6 sites
Study site
Irkutsk, 664003
Study site
Krasnodar, 350063
Study site
Moscow, 115280
Study site
Saint Petersburg, 197374
Study site
Saint Petersburg, 199034
Study site
Smolensk, 214019
About this study
Official title: Multicenter, Open-label, Uncontrolled Study to Investigate Suppression of Ovarian Activity of a Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene in 80 Young Female Volunteers Over 3 Treatment Cycles
The purpose of this study is to look into the effectiveness of a new investigational medication applied as a transdermal patch. The patch is applied on the skin with study medication that is absorbed through the skin suppressing ovarian activity and therefore preventing an egg from leaving an ovary (ovulation). The study will look into the study drug's safety and how well it is tolerated and its absorption, breakdown and elimination in the body. It describes how the body affects a specific drug after administration.
- Conditions
- Contraception
- Being tested
- Gestodene/EE Patch (BAY86-5016)
- Keywords
- Contraception, Transdermal contraceptive patch, Safety, Efficacy, Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gestodene/EE Patch (BAY86-5016)Drug
7 day patch containing 0.55 mg ethinyl estradiol and 2.1 gestodene in a 21 day regimen.
| Study group | Role | What they receive |
|---|---|---|
| Gestodene/EE Patch | Experimental | Not described Receives: Drug: Gestodene/EE Patch (BAY86-5016) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suppression of ovulatory activity proved by progesterone and estradiol concentrations
Estradiol levels > 100pmol/L indicate some ovarian activity and progesterone levels > 5nmol/L in subjects with estradiol levels > 100pmol/L reflect ovulation or luteinized unruptured follicles.
Measured: Treatment day 29 to day 84
Secondary outcomes (7)
Serum concentration, AUC (area under curve) of Gestodene
Measured: Multiple time points up to treatment day 84
Serum concentration, AUC (area under curve) of ethinyl estradiol
Measured: Multiple time points up to treatment day 84
Serum concentration, AUC (area under curve) of Sexual hormone binding globulin
Measured: Multiple time points up to treatment day 84
Number of patients with adverse events
Measured: Up to 84 days
Number of patients with abnormal safety laboratory
Measured: Up to 84 days
Time course of follicle-stimulating hormone
Serum concentration of follicle-stimulating hormone (FSH)
Measured: Day 27 of pretreatment cycle to treatment day 83
Time course of luteinizing hormone
Serum concentration of luteinizing hormone (LH)
Measured: Day 27 of pretreatment cycle to treatment day 83
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study start18 Sep 2015
- Primary completion15 Jul 2016
- Study completion15 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 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
- NCT02550977
- Sponsor's protocol ID
- 16119
- Status last verified
- Jul 2017
- First submitted
- 2 Sep 2015
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label, Uncontrolled Study to Investigate Suppression of Ovarian Activity of a Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene in 80 Young Female Volunteers Over 3 Treatment Cycles
- ClinicalTrials.gov ID
- NCT02550977
- Acronym / sponsor ID
- 16119
- Conditions
- Contraception
- Keywords
- Contraception, Transdermal contraceptive patch, Safety, Efficacy, Pharmacokinetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2015 (actual)
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 15 Aug 2016 (actual)
- First posted
- 16 Sep 2015 (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 purpose of this study is to look into the effectiveness of a new investigational medication applied as a transdermal patch. The patch is applied on the skin with study medication that is absorbed through the skin suppressing ovarian activity and therefore preventing an egg from leaving an ovary (ovulation). The study will look into the study drug's safety and how well it is tolerated and its absorption, breakdown and elimination in the body. It describes how the body affects a specific drug after administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gestodene/EE Patch | Experimental | Drug: Gestodene/EE Patch (BAY86-5016) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy female subjects requesting contraception
- Aged 18 to 35 years (inclusive); smokers must not be older than 30 years
- Normal or clinically insignificant cervical smear not requiring further follow-up
- History of regular cyclic menstrual periods
- Willingness to use nonhormonal methods of contraception during the entire study
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Obesity (body mass index [BMI] > 30.0 kg/m2)
- Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape
- Any disease or condition that may worsen under hormonal treatment
- Use of hormonal contraception other than study medication during the study
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 |
|---|---|---|
| Gestodene/EE Patch (BAY86-5016)7 day patch containing 0.55 mg ethinyl estradiol and 2.1 gestodene in a 21 day regimen. | Drug | Gestodene/EE Patch |
Primary outcome
Suppression of ovulatory activity proved by progesterone and estradiol concentrations
Time frame: Treatment day 29 to day 84
Estradiol levels > 100pmol/L indicate some ovarian activity and progesterone levels > 5nmol/L in subjects with estradiol levels > 100pmol/L reflect ovulation or luteinized unruptured follicles.
7 secondary outcomes
Serum concentration, AUC (area under curve) of Gestodene
Time frame: Multiple time points up to treatment day 84
Serum concentration, AUC (area under curve) of ethinyl estradiol
Time frame: Multiple time points up to treatment day 84
Serum concentration, AUC (area under curve) of Sexual hormone binding globulin
Time frame: Multiple time points up to treatment day 84
Number of patients with adverse events
Time frame: Up to 84 days
Number of patients with abnormal safety laboratory
Time frame: Up to 84 days
Time course of follicle-stimulating hormone
Time frame: Day 27 of pretreatment cycle to treatment day 83
Time course of luteinizing hormone
Time frame: Day 27 of pretreatment cycle to treatment day 83
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 7 Aug 2017.
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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
8 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 Gestodene/EE Patch (BAY86-5016) in people with Contraception, run by Bayer at 8 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 6 inclusion and 5 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 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Russia, Ukraine. 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?
Suppression of ovulatory activity proved by progesterone and estradiol concentrations (time frame: Treatment day 29 to day 84). 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 7 Aug 2017.