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Completed

NCT Number: NCT00401219

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

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.

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Key information

Conditions

Estrogen Replacement Therapy

Age range

35 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

conjugated estrogens/progestin (MPA)

Drug

Primary outcomes

  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-¥.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Nov 20, 2006
Registry last updated
Dec 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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