Pharmacokinetics of Injectable Estradiol and Progesterone Microspheres Suspension

Menopause Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293747
• Other study ID #: 0903/I/PRO
• Status: Completed
• Phase: Phase 1
• First received: February 10, 2011
• Last updated: October 12, 2011
• Start date: February 2011
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: Productos Científicos S. A. de C. V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaría de Salud
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Menopause

Intervention

Drug:
• Estradiol + Progesterone
Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.
• Estradiol + Progesterone
Estradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.

Locations

Country	Name	City	State
Mexico	Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)	Pachuca	Hidalgo

Sponsors (1)

Lead Sponsor	Collaborator
Productos Científicos S. A. de C. V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics	Estrogen and progesterone plasma concentrations and pharmacokinetic parameters.	0 - 60 Days	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	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).	0 - 60 days	Yes