Infertility Clinical Trial
Official title:
Randomized, Controlled, Open-label, Parallel, Clinical Trial to Assess Pharmacokinetics and Endometrial Effect of an Injectable Formulation of Progesterone Microspheres in Doses of 50 mg, 100 mg, 200 mg and 300 mg, in Postmenopausal Women.
Phase: I pharmacokinetic - pharmacodynamic (PK-PD) study. Main objective: To establish the
minimum effective dose of progesterone microspheres suspension, which administered by weekly
intramuscular injection, will be able to induce transformation from a proliferative
endometrium to a secretory endometrium.
Study design: Randomized, controlled, open-label, parallel, dose-response clinical trial.
Sites: 1 Subjects: 48 postmenopausal women.
Sites: 1 Phase: 1 Main objective:To establish the minimum effective dose of progesterone
microspheres suspension, which administered by weekly intramuscular injection, will be able
to induce transformation from a proliferative endometrium to a secretory endometrium.
Secondary objectives:
- To determine and compare the steady-state pharmacokinetic profile of investigational
products.
- To evaluate safety profile of investigational products in the study subjects.
- To evaluate local tolerability of investigational products in the study subjects.
Study design:Randomized, controlled, open-label, parallel, dose-response clinical trial.
Investigational products:
- Progesterone microspheres intramuscular injectable suspension 50 mg
- Progesterone microspheres intramuscular injectable suspension 100 mg
- Progesterone microspheres intramuscular injectable suspension 200 mg
- Progesterone microspheres intramuscular injectable suspension 300 mg Study subjects: 48
healthy postmenopausal women, 45 - 60 years. Brief description: After written informed
consent, 48 eligible women will receive pretreatment with oral estradiol valerate,
then, 14 days later, those with adequate endometrial thickness evaluated through
ultrasound will be randomized to study treatments (one IM injection each 7 days, for a
total of 7 doses). 10 days after the first progesterone dose, an endometrial biopsy
will be obtained. Blood samples will be obtained for pharmacokinetic study.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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