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Sponsored by: |
IBSA Institut Biochimique SA |
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Information provided by: | IBSA Institut Biochimique SA |
ClinicalTrials.gov Identifier: | NCT00377923 |
This is a multiple dose, observer blind, randomised, parallel groups pharmacodynamic and pharmacokinetic study to assess the endometrial effects (predecidual changes) of a new aqueous progesterone formulation administered s.c. at the dose of 25 and 50 mg/day.
Condition | Intervention | Phase |
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Healthy |
Drug: Progesterone |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Estimated Enrollment: | 24 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | March 2006 |
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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 05A/Prg05 |
Study First Received: | September 18, 2006 |
Last Updated: | September 19, 2006 |
ClinicalTrials.gov Identifier: | NCT00377923 |
Health Authority: | Austria: Federal Ministry for Health and Women |
pharmacodynamic and pharmacokinetic study Progesterone healthy volunteers Endometrial decidualisation |
Progesterone Healthy |
Progestins Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions |