NCT00377923

Endometrial Effects of Daily Progesterone s.c. 25 and 50 Mg Aqueous Formulation to Female Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (planned)
• Sponsor: IBSA Institut Biochimique SA · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Progesterone

Timeline

• Start date: 2005-08-01
• Completion: 2006-03-01
• First posted: 2006-09-19
• Last updated: 2006-09-20