Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women

An Open-Label, Single-Dose, Randomized, 4-Period, Partial Crossover Bioequivalence/Bioavailability Study Among Four New Formulations of Premarin 0.45 mg/Medroxyprogesterone Acetate (MPA) 1.5 mg Compared With a Reference Formulation of Premarin/MPA (Prempro) 0.45 mg/1.5 mg in Healthy Postmenopausal Women

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00380887

Enrollment

Registered

2006-09-27

Start date

2005-06-30

Completion date

Unknown

Last updated

2006-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopause

Keywords

bioavailability, bioequivalence, marketed product, Premarin, Medroxyprogesterone acetate, MPA, Postmenopausal, vasomotor symptoms

Brief summary

The purpose of this study is to determine bioequivalence and bioavailability of four different Premarin/MPA test formulations versus the current formulation for Prempro.

Interventions

DRUGPremarin

Study design

Observational model

DEFINED_POPULATION

Time perspective

OTHER

Eligibility

Sex/Gender

FEMALE

Age

35 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy postmenopausal women aged 35 to 70 years 2. Nonsmoker or smoker of less than 10 cigarettes per day

Exclusion criteria

1. History or presence of clotting disorders 2. History or presence of cancer 3. Presence of HIV, hepatitis B or hepatitis C 4. History of drug or alcohol abuse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026