Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Formulations A and B of Premarin/MPA/ and PREMPRO · 1 trial · 2 indications
| Name | Type | Description |
|---|---|---|
| Formulations A and B of Premarin/MPA 0.45 mg/0.5 mg and PREMPRO0.45 mg/0.5 mg | DRUG | - |
Inclusion Criteria: * Healthy, postmenopausal women ages 35 to 70 years, inclusive. * Naturally postmenopausal women must not have had a menstrual period for at least six months, but less than 12 months, as confirmed by a blood test; or for at least 12 months with no blood hormone test confirmation...
These formulations are being studied for postmenopausal osteoporosis. They combine conjugated estrogens (Premarin) with medroxyprogesterone acetate (MPA), the components of PREMPRO. The research focuses on postmenopausal women, and the studied indication is postmenopausal osteoporosis in the endocrine therapeutic area.
Pfizer, Inc. is the developer of these formulations. Pfizer trades on the New York Stock Exchange under the ticker PFE. The company is responsible for the Premarin and PREMPRO product lines and for the bioequivalence study evaluating these new formulations.
These formulations are in Phase 1 development. The single registered trial, NCT00381251, is a Phase 1 bioequivalence study that has been completed. The formulations are investigational, and the available information does not indicate FDA approval for these specific new formulations.
One trial is registered: NCT00381251, titled Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation. It is a completed Phase 1 study in postmenopausal osteoporosis and postmenopause, enrolling healthy female volunteers aged 35 years and older. It was uncontrolled, with no randomization or blinding.
The formulations combine conjugated estrogens with medroxyprogesterone acetate, a progestin. They are small molecule products studied in postmenopausal osteoporosis. The trial compared the bioequivalence of two new formulations against a Premarin/MPA reference formulation in healthy postmenopausal female volunteers.