Clinical Trials Logo
  1. Home
  2. Postmenopause
  3. NCT00543634
  4. Details
NCT00543634 Clinical Trial

Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women

Postmenopause Clinical Trial

Official title:
Open-Label, Single-Dose, Partially Randomized, 6-Period, 6-Treatment, Crossover Bioavailability Study of 3 Pilot Formulations of Premarin®/Medroxyprogesterone Acetate (MPA) Compared With Reference Formulations of Premarin®/MPA (PREMPRO®) and MPA Suspension (Provera®) in Healthy Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00543634
Other study ID # 0713E1-1138
Secondary ID
Status Completed
Phase Phase 1
First received October 3, 2007
Last updated June 17, 2010
Start date October 2007
Est. completion date December 2007

Study information
Verified date June 2010
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 35 Years to 70 Years
Eligibility - Healthy postmenopausal women aged 35 to 70 years with spontaneous or surgical amenorrhea

- BMI in the range of 18 to 35 kg/m2

- History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic)

- History of drug allergy, particularly to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs)

- Use of any prescription or investigational drug within 30 days before test article administration

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Drug:
• Premarin/MPA
0.625 mg/2.5 mg X4
• Premarin/MPA
0.625 mg/5 mg X 2
• Provera 10 mg
2.5 mg of MPA, 4 tablets dissoved in water

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer MDS Pharma Services

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA). 4 days No
See also
  Status Clinical Trial Phase
Completed NCT05448079 - The Effect of Sexual Counseling Given According to the PLISSIT Model on FSFI, MAS and SQOL-F of Postmenopausal Women N/A
Completed NCT00745173 - Study Evaluating Premarin and Bazedoxifene Potential Interaction Phase 1
Completed NCT00913926 - Effects of Wellnara on Climacteric Symptoms N/A
Completed NCT00550433 - Study Evaluating Bazedoxifene/CE in Postmenopausal Women Phase 1
Completed NCT00515593 - PROPOSE Quality - PReOtact in Postmenopausal OStEoporosis - Quality of Life Study (FP-004-DE) N/A
Completed NCT00381251 - Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation. Phase 1
Completed NCT00185328 - Efficacy and Tolerability of Angeliq in Thai Women Phase 4
Completed NCT00484107 - Tolerability & Safety of Premarin Vaginal Cream in Indian Postmenopausal Women Phase 4
Completed NCT00023543 - Reduction of Triglycerides in Women on Hormone Replacement Therapy Phase 2
Completed NCT00006407 - Sex Steroid Hormones and Risk of CHD in Women N/A
Completed NCT00152282 - A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women Phase 2
Completed NCT00006539 - Thrombotic, Inflammatory & Gene Markers of CVD in Women N/A
Completed NCT00010712 - Effects of Black Cohosh on Menopausal Hot Flashes Phase 2
Completed NCT00005515 - Mutations, Hormone Therapy (HRT) and Venous Thromboembolism N/A
Completed NCT00001752 - Vascular and Metabolic Effects of Hormone Therapy Combined With L-Arginine in Postmenopausal Women Phase 2
Completed NCT00000481 - Women's Health Trial: Feasibility Study in Minority Populations Phase 3
Completed NCT00000466 - Postmenopausal Estrogen/Progestin Interventions (PEPI) Phase 3
Completed NCT06115577 - Endometrial Tissues and Mononuclear Cells Receptivity in Pathogenesis of Endometrial Proliferative Processes
Completed NCT01556737 - Effect of Two Different Isoflavone Supplement Preparations on Gene-expression in Postmenopausal Women N/A
Completed NCT00455741 - Postmenopausal Women Estrogen and Progesterone Infusion Phase 1/Phase 2