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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