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

NCT00630435 | Completed Phase 1

• 1 other identifier: 0713E1-1137
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Menopause

Keywords

Premarin®

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of Premarin® and medroxyprogesterone acetate between test and currently marketed formulations

  14 weeks

Secondary Outcomes (1)

• No secondary outcome

  No time frame

Study Arms (4)

1

EXPERIMENTAL

Drug: Premarin®/MPA formulation A

2

EXPERIMENTAL

Drug: Premarin®/MPA formulation B

3

EXPERIMENTAL

Drug: Premarin®/MPA formulation C

4

ACTIVE COMPARATOR

Drug: Premarin®/MPA currently marketed product

Interventions

Premarin®/MPA formulation A DRUG

1

Premarin®/MPA formulation B DRUG

2

Premarin®/MPA formulation C DRUG

3

Premarin®/MPA currently marketed product DRUG

4

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy postmenopausal women aged 35 to 70.
• Body mass index of 18 to 35 kg/m2, weight must be at least 50 kg.
• Nonsmoker or smoker of fewer than 10 cigarettes/day.

You may not qualify if:

• 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.
• History within 1 year of study day 1 of alcohol or drug abuse.
• Use of any investigational drug within 30 days before study day 1.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 7, 2008
• Study Start: February 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: February 4, 2009

Record last verified: 2009-02