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Pharmacokinetics of Injectable Estradiol and Progesterone Microspheres Suspension

Information source: Productos Científicos S. A. de C. V.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Menopause

Intervention: Estradiol + Progesterone (Drug); Estradiol + Progesterone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Productos Científicos S. A. de C. V.

Official(s) and/or principal investigator(s):
Roberto Bernardo, MSc, Principal Investigator, Affiliation: Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)

Summary

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

Clinical Details

Official title: 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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pharmacokinetics

Secondary outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability

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.

Eligibility

Minimum age: 45 Years. Maximum age: 65 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Asociación Mexicana para la Investigación Clínica, A. C. (AMIC), Pachuca, Hidalgo 42090, Mexico
Additional Information

Starting date: February 2011
Last updated: October 12, 2011

Page last updated: August 23, 2015

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