PharmacokineticsPhase 1NCT02170038
Clinical Study Investigating the Conversion of the Contraceptive Compound Norethisterone Within the Body Towards the Contraceptive Compound Ethinylestradiol
A Phase 1 study testing Microgynon and Noristerat(BAY86-6308) in people with Pharmacokinetics, run by Bayer at 1 site in Germany.
Trial summary
The clinical phase I study aims at investigating the conversion of the contraceptive compound norethisterone within the body towards the contraceptive compound ethinylestradiol. Therefore concentrations of ethinylestradiol will be measured from blood samples after administration of a single intramuscular dose of… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Microgynon and Noristerat(BAY86-6308)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Mar 2015
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female subject
- Age: 18 to 45 years (inclusive) at the first screening examination / visit
- Body mass index (BMI): above or equal 18 and below or equal 30 kg / m²
- At least 3 months since delivery, abortion, or lactation before the first screening examination / visit
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
- Liver diseases, kidney diseases, metabolic disorders, thyroid disorders and known or suspected malignant or benign tumors
- Presence or a history of venous or arterial thrombotic/thromboembolic events
- Migraine with neurologic symptoms (complicated migraine)
- Clinically significant depression
- Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
- Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, One-way Crossover Study to Assess the in Vivo Formation of Ethinylestradiol Following Single Intramuscular Administration of 200 mg Norethisterone Enantate Compared to Ethinylestradiol Pharmacokinetics After Multiple Doses of a Combined Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel in Healthy Premenopausal Women
The clinical phase I study aims at investigating the conversion of the contraceptive compound norethisterone within the body towards the contraceptive compound ethinylestradiol. Therefore concentrations of ethinylestradiol will be measured from blood samples after administration of a single intramuscular dose of norethisterone. In a comparison arm concentrations of ethinylestradiol will be measured from blood samples after administration of a pill containing ethinylestradiol itself.
- Conditions
- Pharmacokinetics
- Being tested
- Microgynon, Noristerat(BAY86-6308)
- Keywords
- Drug Kinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrogynonDrug
Subjects will receive 21 daily oral doses of Microgynon tablets containing 0.15 mg levonorgestrel und 0.03 mg ethinylestradiol.
Noristerat(BAY86-6308)Drug
Subjects will receive one intramuscular dose of Noristerat (oily solution for intramuscular injection) containing 200 mg norethisterone enantate.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Healthy premenopausal subjects will receive multiple oral doses of Microgynon for 21days Receives: Drug: Microgynon |
| Arm 2 | Experimental | Healthy premenopausal subjects will receive a single intramuscular dose of Noristerat Receives: Drug: Noristerat(BAY86-6308) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed drug concentration of ethinylestradiol at steady state after multiple administrations of Microgynon (Cmax)ss
Measured: At different time points on day 21
Area under the concentration-time curve of ethinylestradiol at steady state after multiple administrations of Microgynon {AUC(0-24)}ss
Measured: At different time points on day 21
Maximum observed drug concentration of ethinylestradiol after single administration of Noristerat (Cmax)
Measured: At different time points upto 8 weeks
Area under the concentration-time curve of ethinylestradiol after single administration of Noristerat (AUC)
Measured: At different time points up to 8 weeks
Maximum observed drug concentration of Norethisterone after single administration of Noristerat (Cmax)
Measured: At different time points up to 8 weeks
Area under the concentration-time curve of Norethisterone after single administration of Noristerat (AUC)
Measured: At different time points up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT02170038
- Sponsor's protocol ID
- 17004
- Other IDs
- 2013-005280-89
- Status last verified
- Feb 2016
- First submitted
- 20 Jun 2014
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, One-way Crossover Study to Assess the in Vivo Formation of Ethinylestradiol Following Single Intramuscular Administration of 200 mg Norethisterone Enantate Compared to Ethinylestradiol Pharmacokinetics After Multiple Doses of a Combined Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel in Healthy Premenopausal Women
- ClinicalTrials.gov ID
- NCT02170038
- Acronym / sponsor ID
- 17004
- Conditions
- Pharmacokinetics
- Keywords
- Drug Kinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 23 Jun 2014 (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 clinical phase I study aims at investigating the conversion of the contraceptive compound norethisterone within the body towards the contraceptive compound ethinylestradiol. Therefore concentrations of ethinylestradiol will be measured from blood samples after administration of a single intramuscular dose of norethisterone. In a comparison arm concentrations of ethinylestradiol will be measured from blood samples after administration of a pill containing ethinylestradiol itself.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: MicrogynonHealthy premenopausal subjects will receive multiple oral doses of Microgynon for 21days |
| Arm 2 | Experimental | Drug: Noristerat(BAY86-6308)Healthy premenopausal subjects will receive a single intramuscular dose of Noristerat |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy female subject
- Age: 18 to 45 years (inclusive) at the first screening examination / visit
- Body mass index (BMI): above or equal 18 and below or equal 30 kg / m²
- At least 3 months since delivery, abortion, or lactation before the first screening examination / visit
Key exclusion criteria (7 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
- Liver diseases, kidney diseases, metabolic disorders, thyroid disorders and known or suspected malignant or benign tumors
- Presence or a history of venous or arterial thrombotic/thromboembolic events
- Migraine with neurologic symptoms (complicated migraine)
- Clinically significant depression
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 |
|---|---|---|
| MicrogynonSubjects will receive 21 daily oral doses of Microgynon tablets containing 0.15 mg levonorgestrel und 0.03 mg ethinylestradiol. | Drug | Arm 1 |
| Noristerat(BAY86-6308)Subjects will receive one intramuscular dose of Noristerat (oily solution for intramuscular injection) containing 200 mg norethisterone enantate. | Drug | Arm 2 |
Primary outcome
Maximum observed drug concentration of ethinylestradiol at steady state after multiple administrations of Microgynon (Cmax)ss
Time frame: At different time points on day 21
Area under the concentration-time curve of ethinylestradiol at steady state after multiple administrations of Microgynon {AUC(0-24)}ss
Time frame: At different time points on day 21
Maximum observed drug concentration of ethinylestradiol after single administration of Noristerat (Cmax)
Time frame: At different time points upto 8 weeks
Area under the concentration-time curve of ethinylestradiol after single administration of Noristerat (AUC)
Time frame: At different time points up to 8 weeks
Maximum observed drug concentration of Norethisterone after single administration of Noristerat (Cmax)
Time frame: At different time points up to 8 weeks
Area under the concentration-time curve of Norethisterone after single administration of Noristerat (AUC)
Time frame: At different time points up to 8 weeks
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 18 Feb 2016.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Microgynon and Noristerat(BAY86-6308) in people with Pharmacokinetics, run by Bayer at 1 site 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 7 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 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Maximum observed drug concentration of ethinylestradiol at steady state after multiple administrations of Microgynon (Cmax)ss (time frame: At different time points on day 21). The study lists 6 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 18 Feb 2016.