Progesteron supplementation (ART) Infertility not able to get pregnant
Conditions
Interventions
The study treatment will consist of a screening and synchronization phase
(about 1 to 42 days) followed by three periods of study drug administration
over 24 days and 4 treatment / pill free days.
Sponsors
Actavis Group PTC ehf
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy female volunteers aged >=18 and
Exclusion criteria
Exclusion criteria: Clinically significant abnormalities at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secretory transformation of the endometrium: It is defined as binary outcome, i.e. the possible outcomes *early secretory* and *late secretory* will be combined to *adequate response* and the outcomes *proliferative*, *bleeding/necrosis of stratum functionale (menstrual)* to *inadequate response*. | — |
Secondary
| Measure | Time frame |
|---|---|
| Histological results with outcomes *early secretory*, *late secretory*, *proliferative* and *bleeding/necrosis of stratum functionale (menstrual)* Endometrial thickness, as assessed by transvaginal ultrasonography Endometrial aspect, as assessed by transvaginal ultrasonography AUC(0-12h) after single dosing on Day 15 based on serum concentrations of progesterone AUC(0-24h) after multiple dosing based on serum concentrations of progesterone (i.e. starting from pre-dose on Day 24/evening, and covering two applications in case of bid treatment regimens) Safety parameters (adverse events, vital signs, safety laboratory). | — |
Countries
Netherlands
Outcome results
None listed