Progesterone Microspheres Pharmacokinetic - Pharmacodynamic (PK-PD) Study
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Progesterone; Progesterone; Progesterone; Progesterone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Progesterone microspheres injectable suspension 50 mg, intramuscular weekly injection for a total of 7 doses.; Progesterone microspheres injectable suspension 100 mg, intramuscular weekly injection for a total of 7 doses.; Progesterone microspheres injectable suspension 200 mg, intramuscular weekly injection for a total of 7 doses.; Progesterone microspheres injectable suspension 300 mg, intramuscular weekly injection for a total of 7 doses.
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Progesterone; Microspheres; postmenopausal; Luteal phase support