Pharmacokinetics of Injectable Estradiol and Progesterone Microspheres Suspension

• Sponsor: Productos Científicos S. A. de C. V. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01293747
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Menopause	Drug: Estradiol + Progesterone; Drug: Estradiol + Progesterone	Phase 1

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Feb 1, 2011
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Estradiol 0.5 mg/Progesterone 15 mg microspheres Estradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension	Drug: Estradiol + Progesterone; Estradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.
Experimental: Estradiol 1 mg/Progesterone 20 mg microspheres Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension	Drug: Estradiol + Progesterone; Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics [0 - 60 Days]

   Estrogen and progesterone plasma concentrations and pharmacokinetic parameters.

Secondary Outcome Measures

1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)	Pachuca	Hidalgo	Mexico	42090

Sponsors and Collaborators

• Productos Científicos S. A. de C. V.

Investigators

• Principal Investigator: Roberto Bernardo, MSc, Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roberto Bernardo Escudero, Principal Investigator, Productos Científicos S. A. de C. V.
• ClinicalTrials.gov Identifier: NCT01293747
• Other Study ID Numbers: 0903/I/PRO
• First Posted: Feb 11, 2011
• Last Update Posted: Oct 13, 2011
• Last Verified: Oct 1, 2011

• Keywords provided by Roberto Bernardo Escudero, Principal Investigator, Productos Científicos S. A. de C. V.: Estrogen; Progesterone; Microspheres; Menopause; Pharmacokinetics
• Additional relevant MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Progesterone

Study Results

No Results Posted as of Oct 13, 2011