ContraceptionPhase 2NCT02490774
To Investigate the Pharmacological Effects, Drug Blood Levels and Safety of an Intrauterine System Releasing the Study Drug BAY1007626 in Comparison to Mirena and Jaydess in Healthy Young Women Treated for 90 Days to Determine the Drug Dose for Further Development
A Phase 2 study testing BAY1007626, Jaydess and Mirena in people with Contraception, run by Bayer at 7 sites in 3 countries.
Trial summary
Investigation of pharmacological effects, drug blood levels and safety of an intrauterine system releasing the study drug BAY1007626 in comparison to Mirena and Jaydess in healthy young women treated for 90 days to determine the drug dose for further development Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- BAY1007626, Jaydess and Mirena
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 22 Jun 2015to 22 Jul 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female subject.
- Willingness to use non-hormonal methods of contraception during the study.
- This applies during the cycle preceding the pre-treatment cycle until the end of follow-up.
- Age at screening: 18-40 years inclusive.
- Body mass index (BMI) at screening: ≥ 18 and ≤ 32 kg/m².
- History of regular cyclic menstrual periods.
- No clinically relevant abnormal findings in the pre-treatment endometrial biopsy.
Who cannot join
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
- Any presence or history of known or suspected malignant tumors, especially any known or suspected breast cancer or other progestin-sensitive cancer.
- Any presence or history of known or suspected benign tumors of the liver or of the pituitary or adrenal gland.
- Amenorrhea (with unknown reason, not amenorrhea due to hormonal treatment) for more than 3 months within the 6 months before the first screening examination.
- Use of short-acting preparations containing sex hormones during the cycle preceding the pre-treatment cycle (oral, transdermal, intravaginal, IUS).
- Use of long-acting preparations containing sex hormones within the 40 weeks before the first screening examination (any long-acting injectable or implant).
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- Clinically relevant findings in the physical examination (e.g. pronounced varicosis, thrombophlebitis, and evidence of peripheral circulatory disturbances).
- Menstrual disorders with suspicion of ovarian failure (e.g., oligomenorrhea, amenorrhea, hypomenorrhea).
- Known bleeding irregularities
- Current or recurrent pelvic inflammatory disease, including pelvic inflammatory disease within 6 month prior to the insertion of the IUS and any active sexually transmitted disease.
- Anovulatory pre-treatment cycle (ovulation has to be observed by day 27 at the latest).
- Positive result of urine pregnancy test.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Germany5 sites
Study site
Berlin, 10115
Study site
Berlin, 13353
Study site
Hamburg, 22159
Study site
Hamburg, 22351
Study site
Hanover, Lower Saxony, 30459
About this study
Official title: Multi-center, Randomized, Comparator-controlled, Single-blind, Parallel-group Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of an Intrauterine System Releasing BAY 1007626, as Compared With Mirena and Jaydess, in a Combined Proof-of-concept and Dose-finding Study in Healthy Pre Menopausal Women Treated for 90 Days
Investigation of pharmacological effects, drug blood levels and safety of an intrauterine system releasing the study drug BAY1007626 in comparison to Mirena and Jaydess in healthy young women treated for 90 days to determine the drug dose for further development
- Conditions
- Contraception
- Being tested
- BAY1007626, Jaydess, Mirena
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1007626Drug
Intrauterine device with 4 different in vitro release rates (low, low to medium, medium, high)
JaydessDrug
Jaydess: Intrauterine device with a nominal in vitro release of 12 µg levonorgestrel/day
MirenaDrug
Mirena: Intrauterine device with a nominal in vitro release of 20 µg levonorgestrel/day
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: BAY1007626, low relase | Experimental | Intrauterine device with a low in vitro release rate Receives: Drug: BAY1007626 |
| Arm 2: BAY1007626, low to medium release | Experimental | Intrauterine device with a low to medium in vitro release rate Receives: Drug: BAY1007626 |
| Arm 3: BAY1007626, medium release | Experimental | Intrauterine device with a medium in vitro release rate Receives: Drug: BAY1007626 |
| Arm 4: BAY 1007626, high release | Experimental | Intrauterine device with a high in vitro release rate Receives: Drug: BAY1007626 |
| Arm 5: Levonorgestrel, Jaydess | Active comparator | Intrauterine device releasing levonorgestrel (Jaydess) Receives: Drug: Jaydess |
| Arm 6: Levonorgestrel, Mirena | Active comparator | Intrauterine device releasing levonorgestrel (Mirena) Receives: Drug: Mirena |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bleeding and spotting days
Measured: Daily recorded during 90 days treatment period
Progestin effects on endometrial histology
Endometrail histology will be evaluated according to standardized criteria, derived from Blaustein's standard pathology textbook and criteria for secretory-type effects caused by exogenous progestins after intrauterine application.
Measured: Data derived from biopsies taken in the pre-treatment cycle, under treatment (between day 42 and day 90 of treatment) and during follow-up (within max. 40 days after IUS removal).
Ovulation(Yes/no)
Measured: Treatment period 90 days
Secondary outcomes (11)
Endometrial thickness
Measured: pre-treatment cycle days 6, 9, 12, 15, 18, 21, 24, 27, 30, treatment period days 1, 13, 27, 41, 44, 48, 51, 55, 58, 62, 65, 69, 72, 76, 79, 83, 86, 90
Bleeding characterization (Intensity, pattern)
Classified using a 5-step scale from "none" to "heavy"
Measured: For 90 day treatment period
Serum levels of estradiol
Measured: Repeatedly under 90 day treatment
Serum levels of progesterone
Measured: Repeatedly under 90 day treatment
Serum levels of luteinizing hormone
Measured: Repeatedly under 90 day treatment
Serum levels of follicle-stimulating hormone
Measured: Repeatedly under 90 day treatment
Cervix function (Insler score)
The cervix function is classified using the 4-step Insler Score
Measured: cycle day 6,9,12,15,18,23,24,27,40, treatment period days 41,44,48,51,55,58,62,65,69,76,79,80,83,90
Number of participants with adverse events as a measure of safety and tolerability.
Measured: up to 5 months
Cmax of BAY1007626
Measured: treatment period days 13,20,30,41,55,62,72, 90, 91, 92,93,
AUC of BAY1007626
Measured: treatment period days 13,20,30,41,55,62,72, 90, 91, 92,93,95
T1/2 of BAY1007626
Measured: treatment period days 13,20,30,41,55,62,72, 90, 91, 92,93,95
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study start22 Jun 2015
- Primary completion26 May 2016
- Study completion22 Jul 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 174 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
- NCT02490774
- Sponsor's protocol ID
- 15731
- Other IDs
- 2013-003980-74
- Status last verified
- Jun 2019
- First submitted
- 2 Jun 2015
- Last updated
- 4 Jun 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 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Comparator-controlled, Single-blind, Parallel-group Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of an Intrauterine System Releasing BAY 1007626, as Compared With Mirena and Jaydess, in a Combined Proof-of-concept and Dose-finding Study in Healthy Pre Menopausal Women Treated for 90 Days
- ClinicalTrials.gov ID
- NCT02490774
- Acronym / sponsor ID
- 15731
- Conditions
- Contraception
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 174 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2015 (actual)
- Primary completion
- 26 May 2016 (actual)
- Study completion
- 22 Jul 2016 (actual)
- First posted
- 7 Jul 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.
Investigation of pharmacological effects, drug blood levels and safety of an intrauterine system releasing the study drug BAY1007626 in comparison to Mirena and Jaydess in healthy young women treated for 90 days to determine the drug dose for further development
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1: BAY1007626, low relase | Experimental | Drug: BAY1007626Intrauterine device with a low in vitro release rate |
| Arm 2: BAY1007626, low to medium release | Experimental | Drug: BAY1007626Intrauterine device with a low to medium in vitro release rate |
| Arm 3: BAY1007626, medium release | Experimental | Drug: BAY1007626Intrauterine device with a medium in vitro release rate |
| Arm 4: BAY 1007626, high release | Experimental | Drug: BAY1007626Intrauterine device with a high in vitro release rate |
| Arm 5: Levonorgestrel, Jaydess | Active comparator | Drug: JaydessIntrauterine device releasing levonorgestrel (Jaydess) |
| Arm 6: Levonorgestrel, Mirena | Active comparator | Drug: MirenaIntrauterine device releasing levonorgestrel (Mirena) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy female subject.
- Willingness to use non-hormonal methods of contraception during the study.
- This applies during the cycle preceding the pre-treatment cycle until the end of follow-up.
- Age at screening: 18-40 years inclusive.
- Body mass index (BMI) at screening: ≥ 18 and ≤ 32 kg/m².
Key exclusion criteria (12 listed)
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
- Any presence or history of known or suspected malignant tumors, especially any known or suspected breast cancer or other progestin-sensitive cancer.
- Any presence or history of known or suspected benign tumors of the liver or of the pituitary or adrenal gland.
- Amenorrhea (with unknown reason, not amenorrhea due to hormonal treatment) for more than 3 months within the 6 months before the first screening examination.
- Use of short-acting preparations containing sex hormones during the cycle preceding the pre-treatment cycle (oral, transdermal, intravaginal, IUS).
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 |
|---|---|---|
| BAY1007626Intrauterine device with 4 different in vitro release rates (low, low to medium, medium, high) | Drug | Arm 1: BAY1007626, low relase, Arm 2: BAY1007626, low to medium release, Arm 3: BAY1007626, medium release, Arm 4: BAY 1007626, high release |
| JaydessJaydess: Intrauterine device with a nominal in vitro release of 12 µg levonorgestrel/day | Drug | Arm 5: Levonorgestrel, Jaydess |
| MirenaMirena: Intrauterine device with a nominal in vitro release of 20 µg levonorgestrel/day | Drug | Arm 6: Levonorgestrel, Mirena |
Primary outcome
Number of bleeding and spotting days
Time frame: Daily recorded during 90 days treatment period
Progestin effects on endometrial histology
Time frame: Data derived from biopsies taken in the pre-treatment cycle, under treatment (between day 42 and day 90 of treatment) and during follow-up (within max. 40 days after IUS removal).
Endometrail histology will be evaluated according to standardized criteria, derived from Blaustein's standard pathology textbook and criteria for secretory-type effects caused by exogenous progestins after intrauterine application.
Ovulation(Yes/no)
Time frame: Treatment period 90 days
11 secondary outcomes
Endometrial thickness
Time frame: pre-treatment cycle days 6, 9, 12, 15, 18, 21, 24, 27, 30, treatment period days 1, 13, 27, 41, 44, 48, 51, 55, 58, 62, 65, 69, 72, 76, 79, 83, 86, 90
Bleeding characterization (Intensity, pattern)
Time frame: For 90 day treatment period
Serum levels of estradiol
Time frame: Repeatedly under 90 day treatment
Serum levels of progesterone
Time frame: Repeatedly under 90 day treatment
Serum levels of luteinizing hormone
Time frame: Repeatedly under 90 day treatment
Serum levels of follicle-stimulating hormone
Time frame: Repeatedly under 90 day treatment
Cervix function (Insler score)
Time frame: cycle day 6,9,12,15,18,23,24,27,40, treatment period days 41,44,48,51,55,58,62,65,69,76,79,80,83,90
Number of participants with adverse events as a measure of safety and tolerability.
Time frame: up to 5 months
Cmax of BAY1007626
Time frame: treatment period days 13,20,30,41,55,62,72, 90, 91, 92,93,
AUC of BAY1007626
Time frame: treatment period days 13,20,30,41,55,62,72, 90, 91, 92,93,95
T1/2 of BAY1007626
Time frame: treatment period days 13,20,30,41,55,62,72, 90, 91, 92,93,95
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 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
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BAY1007626, Jaydess and Mirena in people with Contraception, run by Bayer at 7 sites in 3 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 7 inclusion and 12 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: stopped early, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Netherlands, United Kingdom. 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 was stopped early. Results are not available in the source record.
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 bleeding and spotting days (time frame: Daily recorded during 90 days treatment period). The study lists 3 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 4 Jun 2019.