Clinical Trial ,Phase IPhase 1NCT03210246
Drug-drug Interaction Study: Influence of Vilaprisan on Pharmacodynamics (PD) and Pharmacokinetics (PK) of a Combined Oral Contraceptive (COC)
A Phase 1 study testing Vilaprisan (BAY 1002670) and Microgynon in people with Clinical Trial ,Phase I, run by Bayer at 2 sites in Germany.
Trial summary
This study will be performed as a multi-center, randomized, double-blind study in 60 healthy women (2 groups of 30 women) to investigate ovarian activity during simultaneous intake of a COC (containing the estrogen EE and the progestin LNG) and the progesterone receptor modulator (PRM) vilaprisan. 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
- Clinical Trial ,Phase I
- What is being tested?
- Vilaprisan (BAY 1002670) and Microgynon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 2 sitesGermany
- Study dates
- 17 Jul 2017to 23 Jan 2019
- Phase
- Phase 1
- 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 premenopausal subjects
- Age: 18 to 35 years (inclusive)
- Body mass index (BMI) : ≥18 and ≤30 kg/m²
- Non-smoker for 3 months (former smokers who quit smoking >3 months before the first study drug administration may be included)
Who cannot join
- Incomplete recovery from pre-existing disease for which it can be assumed that the absorption, distribution, excretion, and effect of the study drugs will not be normal
- presence or history of thrombophlebitis, venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Dinox GmbH Berlin
Berlin, 10115
CRS Clinical Research Services Berlin GmbH
Berlin, 13353
About this study
Official title: A Randomized, Double-blind, Parallel-group, Multi-center Study to Investigate the Pharmacodynamics and Pharmacokinetics of a Combined Oral Contraceptive Containing Levonorgestrel (LNG) and Ethinylestradiol (EE) When Given Together With Vilaprisan Over 3 Months in Healthy Women of Reproductive Age
This study will be performed as a multi-center, randomized, double-blind study in 60 healthy women (2 groups of 30 women) to investigate ovarian activity during simultaneous intake of a COC (containing the estrogen EE and the progestin LNG) and the progesterone receptor modulator (PRM) vilaprisan.
- Conditions
- Clinical Trial ,Phase I
- Being tested
- Vilaprisan (BAY 1002670), Vilaprisan Placebo, Microgynon, Microgynon Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vilaprisan (BAY 1002670)Drug
Multiple doses of Vilaprisan for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3.
Vilaprisan PlaceboDrug
Multiple doses of placebo for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3.
MicrogynonDrug
Multiple doses of Microgynon for 3 cycles of 21 days each (day 1-21)
Microgynon PlaceboDrug
For the treatment cycle 1-3, 7 doses of Microgynon placebo on Day 22-28 per cycle and after 3 treatment cycles 7 additional doses of Microgynon placebo on the 7 days after cycle 3 (day 84 - 91).
| Study group | Role | What they receive |
|---|---|---|
| COC + Vilaprisan | Experimental | COC + Vilaprisan (BAY 1002670) Receives: Drug: Vilaprisan (BAY 1002670); Drug: Microgynon; Drug: Microgynon Placebo |
| COC + Placebo | Placebo comparator | COC + Placebo Receives: Drug: Vilaprisan Placebo; Drug: Microgynon; Drug: Microgynon Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with ovulation (i.e. Hoogland score = 6) or risk of ovulation (Hoogland score = 5)
Measured: treatment day 57 to day 84
Number of subjects with a Hoogland score = 4
Measured: treatment day 57 to day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start17 Jul 2017
- Primary completion21 Jun 2018
- Study completion23 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Trial ,Phase IStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 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
- NCT03210246
- Sponsor's protocol ID
- 17670
- Other IDs
- 2016-004532-38, 2016
- Status last verified
- Feb 2019
- First submitted
- 5 Jul 2017
- Last updated
- 28 Feb 2019
- 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 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group, Multi-center Study to Investigate the Pharmacodynamics and Pharmacokinetics of a Combined Oral Contraceptive Containing Levonorgestrel (LNG) and Ethinylestradiol (EE) When Given Together With Vilaprisan Over 3 Months in Healthy Women of Reproductive Age
- ClinicalTrials.gov ID
- NCT03210246
- Acronym / sponsor ID
- 17670
- Conditions
- Clinical Trial ,Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 23 Jan 2019 (actual)
- First posted
- 6 Jul 2017 (actual)
- 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.
This study will be performed as a multi-center, randomized, double-blind study in 60 healthy women (2 groups of 30 women) to investigate ovarian activity during simultaneous intake of a COC (containing the estrogen EE and the progestin LNG) and the progesterone receptor modulator (PRM) vilaprisan.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COC + Vilaprisan | Experimental | Drug: Vilaprisan (BAY 1002670), Drug: Microgynon, Drug: Microgynon PlaceboCOC + Vilaprisan (BAY 1002670) |
| COC + Placebo | Placebo comparator | Drug: Vilaprisan Placebo, Drug: Microgynon, Drug: Microgynon PlaceboCOC + Placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy female premenopausal subjects
- Age: 18 to 35 years (inclusive)
- Body mass index (BMI) : ≥18 and ≤30 kg/m²
- Non-smoker for 3 months (former smokers who quit smoking >3 months before the first study drug administration may be included)
Key exclusion criteria (2 listed)
- Incomplete recovery from pre-existing disease for which it can be assumed that the absorption, distribution, excretion, and effect of the study drugs will not be normal
- presence or history of thrombophlebitis, venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident
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 |
|---|---|---|
| Vilaprisan (BAY 1002670)Multiple doses of Vilaprisan for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3. | Drug | COC + Vilaprisan |
| Vilaprisan PlaceboMultiple doses of placebo for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3. | Drug | COC + Placebo |
| MicrogynonMultiple doses of Microgynon for 3 cycles of 21 days each (day 1-21) | Drug | COC + Placebo, COC + Vilaprisan |
| Microgynon PlaceboFor the treatment cycle 1-3, 7 doses of Microgynon placebo on Day 22-28 per cycle and after 3 treatment cycles 7 additional doses of Microgynon placebo on the 7 days after cycle 3 (day 84 - 91). | Drug | COC + Placebo, COC + Vilaprisan |
Primary outcome
Number of subjects with ovulation (i.e. Hoogland score = 6) or risk of ovulation (Hoogland score = 5)
Time frame: treatment day 57 to day 84
Number of subjects with a Hoogland score = 4
Time frame: treatment day 57 to day 84
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 28 Feb 2019.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vilaprisan (BAY 1002670) and Microgynon in people with Clinical Trial ,Phase I, run by Bayer at 2 sites in Germany.
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 4 inclusion and 2 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 28 Feb 2019. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 subjects with ovulation (i.e. Hoogland score = 6) or risk of ovulation (Hoogland score = 5) (time frame: treatment day 57 to day 84). The study lists 2 primary outcomes in all. 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 28 Feb 2019.