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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00472927

Enrollment

Unknown

Registered

2007-05-14

Start date

2007-05-31

Completion date

2007-08-31

Last updated

2007-12-06

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

Conditions

Postmenopause

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).

Interventions

DRUGPremarin/MPA 0.45 mg/1.5 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

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 * 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

Design outcomes

Primary

Measure	Time frame
Plasma concentration data and PK parameters of MPA and Premarin (esrone and equilin components)	—

Countries

United States

Outcome results

None listed

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