SMP-028/Oral Contraceptive Drug: Drug Interaction study
Completed
- Conditions
- AsthmaRespiratory
- Registration Number
- ISRCTN93391015
- Lead Sponsor
- Dainippon Sumitomo Pharma Europe Ltd (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 22
Inclusion Criteria
1. Healthy female subjects aged 18 to 45 years
2. In good health as determined by:
2.1. Past medical history
2.2. Physical examination
2.3. Electrocardiogram
2.4. Clinical safety laboratory tests
2.5. Urinalysis
Exclusion Criteria
1. Contraindications to the administration of a combined oral contraceptive (OC) pill
2. Other standard exclusion criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Pharmacokinetics: Drug exposure of the components of Microgynon 30® (ethinylestradiol [EE] and levonorgestrel [LNG]) as measured by serum AUC0-tlast and Cmax of EE and LNG on day 21<br>2. Pharmcodynamics:<br>2.1. Clotting times (e.g. prothrombin and activated partial thromboplastin times) measured at day 21<br>2.2. Maximum follicular diameter at day 21<br>2.3. Serum oestradiol, FSH, LH and progesterone levels taken at day 14 and 21<br>2.4. Sex hormone binding globulin (SHBG) at day 21
- Secondary Outcome Measures
Name Time Method 1. Pharmacokinetics: <br>1.1. Drug exposure of SMP-028 as measured by serum AUC0-tlast, and Cmax on day 21<br>1.2. Other PK parameters including Tmax, AUC0-8, ?Z, t1/2, MRT, CL/F and Vz/F for SMP-028, EE and LNG on day 21<br>2. Safety endpoints:<br>2.1. Incidence and severity of adverse events (AEs)<br>2.2. Discontinuations due to AEs<br>2.3. Actual values and changes in values from baseline in standard laboratory safety tests, vital signs, physical examinations and 12-lead ECGs (electrocardiograms)<br><br>Subjects will be provided with subject diary to record timing of OC intake and details of vaginal bleeding.