Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation. - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00381251

Purpose

This study will compare the bioequivalence of two new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and medroxyprogesterone, 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 and MPA provide the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.

Condition	Intervention	Phase
Postmenopausal Osteoporosis Postmenopause	Drug: Formulations A and B of Premarin/MPA 0.45 mg/0.5 mg and PREMPRO0.45 mg/0.5 mg	Phase I

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
Official Title:	An Open-Label, Single-Dose, Randomized, 3-Period, Crossover, Bioequivalence Study Between Two New Formulations of 0.45 mg/1.5 mg Premarin / Medroxyprogesterone Acetate (MPA) Compared With a Reference Formulation of 0.45mg/1.5mg Premarin / MPA (Prempro™) in Healthy Postmenopausal Women.

Resource links provided by NLM:

MedlinePlus related topics: Menopause Osteoporosis

Drug Information available for: Estrogens, conjugated Prempro Medroxyprogesterone

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

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-¥.

Study Start Date:	September 2006
Estimated Study Completion Date:	January 2007

Eligibility

Ages Eligible for Study:	35 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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 5 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381251

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Trial Manager

Wyeth

More Information

No publications provided

Study ID Numbers:	0713E1-134
Study First Received:	September 26, 2006
Last Updated:	June 8, 2007
ClinicalTrials.gov Identifier:	NCT00381251 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Wyeth:

vaginal atrophy
postmenopausal osteoporosis
menopause
hot flashes

Study placed in the following topic categories:

Medroxyprogesterone 17-Acetate
Estrogens
Antineoplastic Agents, Hormonal
Contraceptive Agents
Hormone Antagonists
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Hot Flashes
Osteoporosis
Bone Diseases, Metabolic

Healthy
Contraceptive Agents, Male
Hormones
Bone Diseases
Estrogens, Conjugated (USP)
Musculoskeletal Diseases
Osteoporosis, Postmenopausal
Atrophy
Medroxyprogesterone
Menopause

Additional relevant MeSH terms:

Medroxyprogesterone 17-Acetate
Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Osteoporosis
Bone Diseases, Metabolic

Reproductive Control Agents
Contraceptive Agents, Male
Bone Diseases
Hormones
Pharmacologic Actions
Estrogens, Conjugated (USP)
Musculoskeletal Diseases
Therapeutic Uses
Osteoporosis, Postmenopausal

ClinicalTrials.gov processed this record on July 02, 2009