Contraception Clinical Trial
Official title:
A Study to Characterize the Effect of Food on the Bioavailability of 15 mg Estetrol (E4)/3 mg Drospirenone (DRSP) Tablets in Healthy Female Volunteers
Verified date | June 2016 |
Source | Estetra |
Contact | n/a |
Is FDA regulated | No |
Health authority | Bulgaria: Bulgarian Drug Agency |
Study type | Interventional |
This single-center, open-label, randomized, balanced, single-dose, two-treatment, two-period, two-sequence crossover study was conducted under medical supervision in 28 healthy female volunteers.
Status | Completed |
Enrollment | 28 |
Est. completion date | April 2016 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Overtly healthy females. - Between the ages of 18 and 45 years, inclusive. - Non-smokers who have not used tobacco or nicotine in any form during the 3 months prior to the screening visit. - Between the body mass index (BMI) of 18 and 30 kg/m2, inclusive, and body weight 45kg. - Negative serum pregnancy test results at screening and negative urine pregnancy test results before dosing. - Willing to use double-barrier methods of non-hormonal contraception during the entire study period. Exclusion Criteria: Potential study subjects were not entered into and/or may have been discontinued from the study if any of the following applied: - Use of - progestogen-only contraceptive methods [e.g., minipill, implant or, intrauterine system (IUS)] during the last 3 months prior to the first dose or, - depot progestogen preparations or an injectable hormonal method of contraception (e.g., Depo-Provera) during the last 6 months prior to the first dose. - Use (within 28 days prior to first dose) of other hormonal contraceptive method. - Use of - any prescription drugs (except thyroid hormone supplements) or herbal supplements acting on CYP3A4 functions (e.g., St. John's Wort), within 28 days prior to the first dose until study completion, - any over-the-counter (OTC) medication (including paracetamol) or dietary supplements (vitamins included) within 14 days prior to the first study dose until study completion. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Estetra |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum concentration (Cmax) of estetrol in plasma | PK sampling | From day 1 to 4 during both period 1 and period 2 | No |
Primary | Cmax of drospirenone in plasma | PK sampling | From day 1 to 4 during both period 1 and period 2 | No |
Primary | Area under the plasma concentration versus time curve from time 0 to the last determined concentration (AUC0-tdlc) of estetrol | From day 1 to 4 during both period 1 and period 2 | No | |
Primary | AUC0-tdlc of drospirenone | From day 1 to 4 during both period 1 and period 2 | No | |
Primary | AUC0-inf of estetrol | PK sampling | Day 1 to 4 during both period 1 and period 2 | No |
Primary | AUC0-inf of drospirenone | PK sampling | Day 1 to 4 during both period 1 and period 2 | No |
Secondary | Number of subjects with adverse events as a measure of safety and tolerability | From up to day 28 before randomization (28 day screening/run-in period) to day 4 of the Period 2 | Yes |
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