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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00401219
Other study ID # 0713E1-136
Secondary ID
Status Completed
Phase Phase 1
First received November 17, 2006
Last updated December 4, 2007
Start date November 2006
Est. completion date February 2007

Study information

Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date February 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 35 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
conjugated estrogens/progestin (MPA)


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type Measure Description Time frame Safety issue
Primary 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-¥.
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05483634 - Compare Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause
Completed NCT00883662 - Mirena Observational Program N/A
Completed NCT00318318 - Beneficial Effects of Oral Premarin Estrogen Replacement Therapy Assessed by Human Genome Array Phase 1
Recruiting NCT04050592 - Discontinuation of Postmenopausal Hormone Therapy: Impact on the Cardiovascular System and Quality of Life Phase 4
Recruiting NCT00173550 - Perception and Attitude Toward Estrogen Therapy Among Surgically Menopausal Women N/A