Healthy VolunteerPhase 1NCT01615354
A Study of Aleglitazar in Combination With Oral Contraceptive Healthy Volunteers
A Phase 1 study testing Aleglitazar and Microgynon® in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United Kingdom.
Trial summary
This randomized, double-blind, placebo-controlled, cross-over study will assess the effect of aleglitazar on the pharmacokinetics and pharmacodynamics on Microgynon® in healthy volunteers. Volunteers will receive multiple oral doses of aleglitazar in one period; in the other period volunteers will receive placebo. 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
- Healthy Volunteer
- What is being tested?
- Aleglitazar and Microgynon®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2012to Jan 2013
- 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 volunteer, 18 to 45 years of age
- Body mass index (BMI) between 18.0 and 29.9 kg/m2
- Body weight at least 55.0 kg
- Non-pregnant, not lactating and not planning pregnancy from screening to 3 months after the last dose of study treatment
- Non-smoker for at least 3 months
Who cannot join
- Currently active gynecological disorder
- History of amenorrhea within the previous 3 years
- Known or suspected history of estrogen-dependent neoplasia or sex hormone-dependent malignant tumors
- Use of steroid hormone-containing intrauterine device (IUD) or progesterone-release IUD contraceptive within 3 months to screening.
- History of clinically significant disease that could jeopardize the volunteer safety in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Center, Randomized, Double-Blind, Placebo Controlled, Crossover Study to Assess the Effect of Aleglitazar on the Pharmacokinetics and Pharmacodynamics of Ethinyl Estradiol and Levonorgestrel as Components of the Oral Contraceptive Microgynon®
This randomized, double-blind, placebo-controlled, cross-over study will assess the effect of aleglitazar on the pharmacokinetics and pharmacodynamics on Microgynon® in healthy volunteers. Volunteers will receive multiple oral doses of aleglitazar in one period; in the other period volunteers will receive placebo.
- Conditions
- Healthy Volunteer
- Being tested
- Aleglitazar, Microgynon®, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AleglitazarDrug
Multiple oral doses
Microgynon®Drug
Multiple oral doses
PlaceboDrug
Multiple oral doses
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Microgynon®; Drug: Placebo |
| Treatment | Experimental | Not described Receives: Drug: Aleglitazar; Drug: Microgynon® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of Levonorgestrel: area under the concentration time curve
Measured: pre-dose and up to 24 hours post-dose
Pharmacokinetics of ethinyl estradiol: area under the concentration time curve
Measured: pre-dose and up to 24 hours post-dose
Secondary outcomes (2)
Pharmacodynamics: luteinizing/follicular stimulation hormone concentration
Measured: Days 1, 7, 13, 14, 15, 21
Safety: incidence of adverse events
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615354
- Sponsor's protocol ID
- BP25559
- Status last verified
- Nov 2016
- First submitted
- 6 Jun 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Center, Randomized, Double-Blind, Placebo Controlled, Crossover Study to Assess the Effect of Aleglitazar on the Pharmacokinetics and Pharmacodynamics of Ethinyl Estradiol and Levonorgestrel as Components of the Oral Contraceptive Microgynon®
- ClinicalTrials.gov ID
- NCT01615354
- Acronym / sponsor ID
- BP25559
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Jun 2012 (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.
This randomized, double-blind, placebo-controlled, cross-over study will assess the effect of aleglitazar on the pharmacokinetics and pharmacodynamics on Microgynon® in healthy volunteers. Volunteers will receive multiple oral doses of aleglitazar in one period; in the other period volunteers will receive placebo.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Microgynon®, Drug: Placebo |
| Treatment | Experimental | Drug: Aleglitazar, Drug: Microgynon® |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy female volunteer, 18 to 45 years of age
- Body mass index (BMI) between 18.0 and 29.9 kg/m2
- Body weight at least 55.0 kg
- Non-pregnant, not lactating and not planning pregnancy from screening to 3 months after the last dose of study treatment
- Non-smoker for at least 3 months
Key exclusion criteria (5 listed)
- Currently active gynecological disorder
- History of amenorrhea within the previous 3 years
- Known or suspected history of estrogen-dependent neoplasia or sex hormone-dependent malignant tumors
- Use of steroid hormone-containing intrauterine device (IUD) or progesterone-release IUD contraceptive within 3 months to screening.
- History of clinically significant disease that could jeopardize the volunteer safety in 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 |
|---|---|---|
| AleglitazarMultiple oral doses | Drug | Treatment |
| Microgynon®Multiple oral doses | Drug | Placebo, Treatment |
| PlaceboMultiple oral doses | Drug | Placebo |
Primary outcome
Pharmacokinetics of Levonorgestrel: area under the concentration time curve
Time frame: pre-dose and up to 24 hours post-dose
Pharmacokinetics of ethinyl estradiol: area under the concentration time curve
Time frame: pre-dose and up to 24 hours post-dose
2 secondary outcomes
Pharmacodynamics: luteinizing/follicular stimulation hormone concentration
Time frame: Days 1, 7, 13, 14, 15, 21
Safety: incidence of adverse events
Time frame: 16 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 2 Nov 2016.
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Screening Protocol
Pain
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.
Clinical Trials study director
Hoffmann-La Roche
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 Aleglitazar and Microgynon® in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United Kingdom.
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 5 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 2 Nov 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 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. 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?
Pharmacokinetics of Levonorgestrel: area under the concentration time curve (time frame: pre-dose and up to 24 hours post-dose). 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 2 Nov 2016.