PK/PD trial with different dose regimens of Cyclogest® in comparison to Crinone® and placebo in healthy female subjects
Completed
- Conditions
- Progesteron supplementation (ART)Infertilitynot able to get pregnant10013356
- Registration Number
- NL-OMON37494
- Lead Sponsor
- Actavis Group PTC ehf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 96
Inclusion Criteria
Healthy female volunteers aged >=18 and <= 45 years
Exclusion Criteria
Clinically significant abnormalities at screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Secretory transformation of the endometrium:<br /><br><br /><br>It is defined as binary outcome, i.e. the possible outcomes *early secretory*<br /><br>and *late secretory* will be combined to *adequate response* and the outcomes<br /><br>*proliferative*, *bleeding/necrosis of stratum functionale (menstrual)* to<br /><br>*inadequate response*.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Histological results with outcomes *early secretory*, *late secretory*,<br /><br>*proliferative* and *bleeding/necrosis of stratum functionale (menstrual)*<br /><br><br /><br>Endometrial thickness, as assessed by transvaginal ultrasonography<br /><br><br /><br>Endometrial aspect, as assessed by transvaginal ultrasonography<br /><br><br /><br>AUC(0-12h) after single dosing on Day 15 based on serum concentrations of<br /><br>progesterone<br /><br><br /><br>AUC(0-24h) after multiple dosing based on serum concentrations of progesterone<br /><br>(i.e. starting from pre-dose on Day 24/evening, and covering two applications<br /><br>in case of bid treatment regimens)<br /><br><br /><br>Safety parameters (adverse events, vital signs, safety laboratory).</p><br>