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

Menopause Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630435
• Other study ID #: 0713E1-1137
• Status: Completed
• Phase: Phase 1
• First received: February 28, 2008
• Last updated: February 3, 2009
• Start date: February 2008
• Est. completion date: June 2008

Study information

• Verified date: February 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Menopause

Intervention

Drug:
• Premarin®/MPA formulation A

• Premarin®/MPA formulation B

• Premarin®/MPA formulation C

• Premarin®/MPA currently marketed product

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of Premarin® and medroxyprogesterone acetate between test and currently marketed formulations		14 weeks	No
Secondary	No secondary outcome		No time frame	No