Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00472927
Collaborator
(none)
1
3

Study Details

Study Description

Brief Summary

To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA).

Condition or Disease Intervention/Treatment Phase
  • Drug: Premarin/MPA 0.45 mg/1.5 mg
Phase 1

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of Three New Formulations of Premarin 0.45mg/Medroxyprogesterone Acetate (MPA) 1.5mg Compared With a Reference Formulation of Premarin/MPA (PremproTM) 0.45mg/1.5mg in Healthy Postmenopausal Women
Study Start Date :
May 1, 2007
Actual Study Completion Date :
Aug 1, 2007

Outcome Measures

Primary Outcome Measures

  1. Plasma concentration data and PK parameters of MPA and Premarin (esrone and equilin components) []

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy, postmenopausal women, aged 35 to 70 years

  • Spontaneous amenorrhea for at least 12 months (no FSH required) or spontaneous amenorrhea for at least 6 months (FSH level ≥38 mIU/mL); spontaneous amenorrhea must have begun by the age of 55

  • BMI in the range of 18 to 35 kg/m2

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

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

  • Use of prescription or investigatioanl drugs within 30 days before test article administration

Contacts and Locations

Locations

Site City State Country Postal Code
1 Miami Florida United States 33126

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.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00472927
Other Study ID Numbers:
  • 0713E1-1142
First Posted:
May 14, 2007
Last Update Posted:
Dec 6, 2007
Last Verified:
Dec 1, 2007
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 6, 2007