Endometrial Effects of Daily Progesterone s.c. 25 and 50 Mg Aqueous Formulation to Female Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT00377923|
Recruitment Status : Completed
First Posted : September 19, 2006
Last Update Posted : September 20, 2006
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Progesterone||Phase 1|
This study is designed in order to assess the efficacy of the investigational product (Progesterone acqueous s.c. formulation) when it is administered at the dose of 25 and 50 mg. The induced predecidual changes will be evaluated through endometrial bioptic samplings, performed on day 11 and will be compared between the two treatment groups.
The pharmacokinetic evaluation was designed according to internationally recognised guidelines for PK studies.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||August 2005|
|Estimated Study Completion Date :||March 2006|
- partial and full predecidual changes in endometrial samples on the 11th day of exposure to the IMP compared to the findings on the 11th day after ovulation in the menstrual cycle, according to Noyes criteria
- PK profile of progesterone at the steady-state following the 25 or 50 mg/day of progesterone s.c. at the time of endometrial biopsy, local tolerability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377923
|Principal Investigator:||Markus Müller, Prof||Department of Clinical Pharmacology, AKH, Vienna, Austria.|