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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00543634

Enrollment

Registered

2007-10-15

Start date

2007-10-31

Completion date

2007-12-31

Last updated

2010-06-22

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

Conditions

Postmenopause

Brief summary

The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).

Interventions

DRUGPremarin/MPA

0.625 mg/2.5 mg X4

DRUGProvera 10 mg

2.5 mg of MPA, 4 tablets dissoved in water

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

35 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA).	4 days

Countries

United States

Outcome results

None listed

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