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Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference Formulation

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ClinicalTrials.gov Identifier: NCT00401219
Recruitment Status : Completed
First Posted : November 20, 2006
Last Update Posted : December 6, 2007
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
This study will compare the bioavailabity of three new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and MPA, Prempro™. Prempro™ is indicated for use after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). The purpose of this study is to determine if these new formulations of Premarin/MPA provide the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.

Condition or disease Intervention/treatment Phase
Estrogen Replacement Therapy Drug: conjugated estrogens/progestin (MPA) Phase 1

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioavailability Study Among 3 New Formulations of Premarin 0.625 mg/Medroxyprogesterone Acetate (Mpa) 2.5 mg Compared With a Reference Formulation of Premarin/Mpa (Prempro) 0.625 mg/2.5 mg in Healthy Postmenopausal Women
Study Start Date : November 2006
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Pharmacokinetic blood samples for unconjugated and total (unconjugated plus conjugated) estrogens and MPA will be obtained. The following pharmacokinetic parameters will be determined: Cmax, Tmax, t½, AUC0-T, AUC0-¥.

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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. Naturally postmenopausal women must not have had a menstrual period since the age of 54. Surgically menopausal women must have undergone bilateral oophorectomy (removal of both ovaries) at least 6 months prior to the start of the study, and the surgical report may be requested to confirm the surgery date and that the surgery was not due to a cancerous condition.
  • Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401219

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
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ClinicalTrials.gov Identifier: NCT00401219    
Other Study ID Numbers: 0713E1-136
First Posted: November 20, 2006    Key Record Dates
Last Update Posted: December 6, 2007
Last Verified: December 2007
Additional relevant MeSH terms:
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Estrogens, Conjugated (USP)
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs