Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women

Postmenopause Clinical Trial

Official title:

Open-Label, Single-Dose, Partially Randomized, 6-Period, 6-Treatment, Crossover Bioavailability Study of 3 Pilot Formulations of Premarin®/Medroxyprogesterone Acetate (MPA) Compared With Reference Formulations of Premarin®/MPA (PREMPRO®) and MPA Suspension (Provera®) in Healthy Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00543634
• Other study ID #: 0713E1-1138
• Status: Completed
• Phase: Phase 1
• First received: October 3, 2007
• Last updated: June 17, 2010
• Start date: October 2007
• Est. completion date: December 2007

Study information

• Verified date: June 2010
• 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 the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

• Healthy postmenopausal women aged 35 to 70 years with spontaneous or surgical amenorrhea

• BMI in the range of 18 to 35 kg/m2

• History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic)

• History of drug allergy, particularly to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs)

• Use of any prescription or investigational drug within 30 days before test article administration

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Postmenopause

Intervention

Drug:
• Premarin/MPA
0.625 mg/2.5 mg X4
• Premarin/MPA
0.625 mg/5 mg X 2
• Provera 10 mg
2.5 mg of MPA, 4 tablets dissoved in water

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA).		4 days	No