Oral ContraceptivesPhase 1NCT01110525
A Drug-drug Interaction Study to Investigate the Effects of AZD1981 on the Metabolism and Pharmacodynamics of Oral Contraceptives
A Phase 1 study testing AZD1981 and Neovletta 21/28 in people with Oral Contraceptives, run by AstraZeneca at 2 sites in Sweden.
Trial summary
The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the metabolism of hormones included in oral contraceptives. 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
- Oral Contraceptives
- What is being tested?
- AZD1981 and Neovletta 21/28
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesSweden
- Study dates
- May 2010to Oct 2010
- 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
- Females of childbearing potential
- Use of Neovletta or Neovletta 28 minimum 3 months prior to enrolment.
- Willing to use a highly effective method of birth control, ie, double barrier method contraception.
Who cannot join
- Pregnancy and/or lactation or delivery/abortion within 6 months prior to randomisation.
- Any clinically significant disease or disorder.
- Any clinically relevant abnormal findings in physical examination.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase I, Double-blind, Randomised, Placebo-controlled, Two-cycle Crossover, Drug-drug Interaction Study to Investigate the Effects of AZD1981 Tablets 400 mg Twice Daily on the PK and PD of Oral Contraceptives in Healthy Female Volunteers
The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the metabolism of hormones included in oral contraceptives.
- Conditions
- Oral Contraceptives
- Being tested
- AZD1981, Neovletta 21/28, Placebo AZD1981
- Keywords
- Phase I, Drug-drug interaction, Oral contraceptives, AZD 1981
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1981Drug
4X100 mg per oral, twice daily for 28 days
Neovletta 21/28Drug
Once daily with (21) or without (28) pause for bleeding.
Placebo AZD1981Drug
4X100 mg per oral, twice daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD1981 + Oral contraceptive Receives: Drug: AZD1981; Drug: Neovletta 21/28 |
| 2 | Placebo comparator | Placebo + Oral contraceptive Receives: Drug: Neovletta 21/28; Drug: Placebo AZD1981 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of of EE and LNG by analysis of the AUC and Css,max.
Measured: PK sampling will be performed regularly during the study period of two months.
Secondary outcomes (3)
Effect on LH, FSH, SHBG, progesterone, and E2 during the menstrual cycle: Serum concentrations of LH, FSH, SHBG, progesterone and E2
Measured: PD sampling will be done at the end of treatment period 1 and 2.
Safety and tolerability of the combination: Adverse events, safety laboratory variables, pulse, blood pressure, electrocardiogram and physical examinations
Measured: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study.
Steady state PK of 1981 in combo with oral contraceptives AUCτ, Css,max, time to Cmax during a dosing interval (tmax ss);apparent plasma clearance (CLss/F) of AZD1981(tmax ss) of EE and LNG; Morning Ctrough values of EE and LNG will be measured.
Measured: PK-sampling of AZD1981 wil be done at the end of treatment period 1 and 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral ContraceptivesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eva S Pettersson, Study director, AstraZeneca R&DWolfgang Kühn, Principal investigator, Quintiles AB, Phase I ServicesAslak Rautio, Principal investigator, Quintiles Hermelinen AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110525
- Sponsor's protocol ID
- D9830C00015
- Other IDs
- 2010-018864-18
- Status last verified
- Nov 2010
- First submitted
- 1 Apr 2010
- Last updated
- 18 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double-blind, Randomised, Placebo-controlled, Two-cycle Crossover, Drug-drug Interaction Study to Investigate the Effects of AZD1981 Tablets 400 mg Twice Daily on the PK and PD of Oral Contraceptives in Healthy Female Volunteers
- ClinicalTrials.gov ID
- NCT01110525
- Acronym / sponsor ID
- D9830C00015
- Conditions
- Oral Contraceptives
- Keywords
- Phase I, Drug-drug interaction, Oral contraceptives, AZD 1981
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 26 Apr 2010 (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 primary purpose of this study is to determine whether the treatment with AZD1981 will affect the metabolism of hormones included in oral contraceptives.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD1981, Drug: Neovletta 21/28AZD1981 + Oral contraceptive |
| 2 | Placebo comparator | Drug: Neovletta 21/28, Drug: Placebo AZD1981Placebo + Oral contraceptive |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Females of childbearing potential
- Use of Neovletta or Neovletta 28 minimum 3 months prior to enrolment.
- Willing to use a highly effective method of birth control, ie, double barrier method contraception.
Key exclusion criteria (3 listed)
- Pregnancy and/or lactation or delivery/abortion within 6 months prior to randomisation.
- Any clinically significant disease or disorder.
- Any clinically relevant abnormal findings in physical examination.
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 |
|---|---|---|
| AZD19814X100 mg per oral, twice daily for 28 days | Drug | 1 |
| Neovletta 21/28Once daily with (21) or without (28) pause for bleeding. | Drug | 1, 2 |
| Placebo AZD19814X100 mg per oral, twice daily for 28 days | Drug | 2 |
Primary outcome
Pharmacokinetics of of EE and LNG by analysis of the AUC and Css,max.
Time frame: PK sampling will be performed regularly during the study period of two months.
3 secondary outcomes
Effect on LH, FSH, SHBG, progesterone, and E2 during the menstrual cycle: Serum concentrations of LH, FSH, SHBG, progesterone and E2
Time frame: PD sampling will be done at the end of treatment period 1 and 2.
Safety and tolerability of the combination: Adverse events, safety laboratory variables, pulse, blood pressure, electrocardiogram and physical examinations
Time frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study.
Steady state PK of 1981 in combo with oral contraceptives AUCτ, Css,max, time to Cmax during a dosing interval (tmax ss);apparent plasma clearance (CLss/F) of AZD1981(tmax ss) of EE and LNG; Morning Ctrough values of EE and LNG will be measured.
Time frame: PK-sampling of AZD1981 wil be done at the end of treatment period 1 and 2.
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 Nov 2010.
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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.
Eva S Pettersson study director
AstraZeneca R&D
Wolfgang Kühn principal investigator
Quintiles AB, Phase I Services
Aslak Rautio principal investigator
Quintiles Hermelinen AB
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 AZD1981 and Neovletta 21/28 in people with Oral Contraceptives, run by AstraZeneca at 2 sites in Sweden.
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 3 inclusion and 3 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 Nov 2010. 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 Sweden. 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 of EE and LNG by analysis of the AUC and Css,max. (time frame: PK sampling will be performed regularly during the study period of two months.). 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 Nov 2010.