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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
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.
Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)
Pachuca, Hidalgo, Mexico
Endometrial dating through histopathologic criteria.
Endometrial dating according Noyes criteria as a measure of efficacy. At the moment of the biopsy, study subjects would have received 25 days of estradiol valerate pretreatment and 10 days of progesterone (investigational product); thus simulating the 25th day of a menstrual cycle. Efficacy will be measured as number of biopsies that have histological date according to cronological date.
Time frame: 10 days
Pharmacokinetics
Progesterone plasmatic concentrations and pharmacokinetic parameters.
Time frame: 0 -60 days.
Adverse events
Number of Participants with Adverse Events as a Measure of Safety and Tolerability Pain Scores on a Visual Analog Scale
Time frame: 0 - 65 days
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Progesterone microspheres injectable suspension 300 mg, intramuscular weekly injection for a total of 7 doses.