Clinical Trials Logo
  1. Home
  2. Postmenopause
  3. NCT00152282

A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women

Postmenopause Clinical Trial

Official title:
A Phase II Pilot Study to Evaluate the Safety and Efficacy of J867 Administered With Estrogen to Postmenopausal Women

Clinical Trial Summary

The objective of this study is to determine the safety and effectiveness of 3 asoprisnil doses when administered to postmenopausal women with Premarin® 0.625 mg.

Clinical Trial Description

The objective of this study is to determine the safety and effectiveness of asoprisnil 5, 10, and 25 mg, compared to placebo, when administered to postmenopausal women, with Premarin® 0.625 mg, for 12 weeks. Pharmacodynamic effects to be assessed include bleeding pattern, endometrial biopsy results, and endometrial thickness. Safety assessments will include clinical laboratory results, physical examination with vital signs, pelvic and breast examinations, ultrasound results, and adverse events ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00152282
Study type Interventional
Source Abbott
Contact
Status Completed
Phase Phase 2
Start date September 2000
Completion date August 2001
View Details
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 NCT00550433 - Study Evaluating Bazedoxifene/CE in Postmenopausal Women Phase 1
Completed NCT00913926 - Effects of Wellnara on Climacteric Symptoms N/A
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 NCT00006539 - Thrombotic, Inflammatory & Gene Markers of CVD in Women N/A
Completed NCT00010712 - Effects of Black Cohosh on Menopausal Hot Flashes Phase 2
Completed NCT00001752 - Vascular and Metabolic Effects of Hormone Therapy Combined With L-Arginine in Postmenopausal Women Phase 2
Completed NCT00005515 - Mutations, Hormone Therapy (HRT) and Venous Thromboembolism N/A
Completed NCT00000481 - Women's Health Trial: Feasibility Study in Minority Populations Phase 3
Completed NCT00000466 - Postmenopausal Estrogen/Progestin Interventions (PEPI) Phase 3
Completed NCT00543634 - Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women Phase 1
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