Pharmacokinetics of Injectable Estradiol and Progesterone Microspheres Suspension
Overview
Phase I pharmacokinetic study Main objective: To determine plasmatic profiles and pharmacokinetic parameters of estradiol and progesterone on each of the formulations studied, after multiple-dose administration Study design: Randomized, controlled, open-label, parallel, pharmacokinetic study Sites: 1 Subjects: 30 postmenopausal women
Full Title of Study: “Multiple-dose Pharmacokinetic Study of Two Aqueous Suspensions of Estradiol and Progesterone Microspheres (1 mg/20 mg & 0.5 mg/15 mg) for Intramuscular Administration, in Postmenopausal Volunteers.”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: August 2011
Detailed Description
Sites: 1 Phase: 1 Main objective: To determine plasmatic profiles and pharmacokinetic parameters of estradiol and progesterone on each of the formulations studied, after multiple-dose administration. Secondary objectives: To determine bioavailability of each of the formulations studied, after multiple-dose-administration. Describe tolerability of each of the formulations studied, after multiple-dose administration. Study design: Randomized, controlled, open-label, parallel, pharmacokinetic study Investigational Products: – Estradiol and progesterone microspheres aqueous suspension (1 mg/20 mg) – Estradiol and progesterone microspheres aqueous suspension (0.5 mg/15 mg) Study subjects: 30 postmenopausal women 45 – 65 years old Brief description: After written informed consent, 30 eligible women will be randomized to study treatments (one IM injection each 28 days, for a total of 4 doses). Blood samples will be obtained for pharmacokinetic study.
Interventions
- Drug: Estradiol + Progesterone
- Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.
- Drug: Estradiol + Progesterone
- Estradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.
Arms, Groups and Cohorts
- Experimental: Estradiol 0.5 mg/Progesterone 15 mg microspheres
- Estradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension
- Experimental: Estradiol 1 mg/Progesterone 20 mg microspheres
- Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension
Clinical Trial Outcome Measures
Primary Measures
- Pharmacokinetics
- Time Frame: 0 – 60 Days
- Estrogen and progesterone plasma concentrations and pharmacokinetic parameters.
Secondary Measures
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- Time Frame: 0 – 60 days
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability. Adverse events will be evaluated through periodic clinical evaluations and laboratory tests (comparison between enrollment and discharge).
Participating in This Clinical Trial
Inclusion Criteria
- Female – 45 to 65 years old – Able to read and write – Postmenopausal – Body Mass Index equal or below 34.99 kg/m2 – Healthy – Normal uterus – Time availability Exclusion Criteria:
- Hypersensitivity to progesterone or related compounds – Hypersensitivity to estrogens – Hysterectomy – History or present hormone-dependent tumor – History or present uterine cervix dysplasia – Abnormal and clinically-significant laboratory test results – Family history of breast cancer – History of thromboembolic disease – Non-controlled hypertension – History of stroke – History of cardiac valve surgery – Renal failure – Hepatic failure – Non-controlled diabetes – History of serious neurologic disease – Reduced mobility – Anemia – Previous or concomitant hormone therapy – Previous or concomitant therapy with inhibitors or inductors of cytochrome
Gender Eligibility: Female
Minimum Age: 45 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Productos Científicos S. A. de C. V.
- Provider of Information About this Clinical Study
- Principal Investigator: Roberto Bernardo Escudero, Principal Investigator – Productos Científicos S. A. de C. V.
- Overall Official(s)
- Roberto Bernardo, MSc, Principal Investigator, Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)
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