Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00630435
• Collaborator: (none)
• Enrollment: 76
• Arms: 4
• Duration (Months): 4

Study Details

Study Description

Brief Summary

The purpose of this trial is to determine the equivalence of 3 new formulations of a Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed dosage form (Prempro® [TM]). This study will be performed in healthy postmenopausal women. Each subject will participate in the study for approximately 14 weeks, including a screening evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with at least a 21-day washout interval between each dose administration.

Condition or Disease	Intervention/Treatment	Phase
Menopause	Drug: Premarin®/MPA formulation A; Drug: Premarin®/MPA formulation B; Drug: Premarin®/MPA formulation C; Drug: Premarin®/MPA currently marketed product	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of 3 New Formulations of Premarin® /MPA 0.625 mg/2.5 mg Compared With Reference Formulation of Premarin®/MPA in Healthy Postmenopausal Women
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Premarin®/MPA formulation A
Experimental: 2	Drug: Premarin®/MPA formulation B
Experimental: 3	Drug: Premarin®/MPA formulation C
Active Comparator: 4	Drug: Premarin®/MPA currently marketed product

Outcome Measures

Primary Outcome Measures

1. Plasma concentrations of Premarin® and medroxyprogesterone acetate between test and currently marketed formulations [14 weeks]

Secondary Outcome Measures

1. No secondary outcome [No time frame]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion

1. Healthy postmenopausal women aged 35 to 70.

2. Body mass index of 18 to 35 kg/m2, weight must be at least 50 kg.

3. Nonsmoker or smoker of fewer than 10 cigarettes/day.

Exclusion

1. History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic). Can take up to 2 antihypertensive medications to keep blood pressure under control.

2. History within 1 year of study day 1 of alcohol or drug abuse.

3. Use of any investigational drug within 30 days before study day 1.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00630435
• Other Study ID Numbers: 0713E1-1137
• First Posted: Mar 7, 2008
• Last Update Posted: Feb 4, 2009
• Last Verified: Feb 1, 2009

• Keywords provided by , ,: Premarin®
• Additional relevant MeSH terms: Estrogens, Conjugated (USP)

Study Results

No Results Posted as of Feb 4, 2009