Clinical Trials Logo
  1. Home
  2. Postmenopause
  3. NCT00185328
  4. Details
NCT00185328 Clinical Trial

Efficacy and Tolerability of Angeliq in Thai Women

Postmenopause Clinical Trial

Official title:
A Multi-Center, Open-Label, Non-Comparative Study Investigating the Efficacy and Tolerability of Angeliq® in Postmenopausal Thai Women With Vasomotor Symptoms Over Three 28-Day Treatment Cycles

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00185328
Other study ID # 91436
Secondary ID 309367
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated December 11, 2008
Start date September 2005
Est. completion date December 2006

Study information
Verified date December 2008
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Thailand: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms.

Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 45 Years and older
Eligibility Inclusion Criteria:

- Postmenopausal women with hot flushes

Exclusion Criteria:

- Women with a contraindication for Hormone Replacement Therapy (HRT)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Estradiol/DRSP (Angeliq, BAY86-4891)
1 tablet of 2 mg drospirenone and 1 mg estradiol, orally administered once daily, over three 28-day treatment cycles

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Outcome
Type Measure Description Time frame Safety issue
Primary The relative change in the frequency of hot flushes At baseline, week 4, 8, 12
Secondary The change in intensity of hot flushes At baseline, week 4, 8, 12
Secondary The relative change in frequency of hot flushes At baseline, week 4, 8
Secondary The change in intensity of hot flushes At baseline, week 4, 8
Secondary The proportions of subjects with urogenital symptoms At baseline, week 4, 8, 12
Secondary Bleeding pattern At baseline, week 4, 8, 12
Secondary Adverse events collection Collection of AE throughout the study period
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 NCT00381251 - Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation. Phase 1
Completed NCT00515593 - PROPOSE Quality - PReOtact in Postmenopausal OStEoporosis - Quality of Life Study (FP-004-DE) N/A
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 NCT00152282 - A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women Phase 2
Completed NCT00006407 - Sex Steroid Hormones and Risk of CHD in Women N/A
Completed NCT00010712 - Effects of Black Cohosh on Menopausal Hot Flashes Phase 2
Completed NCT00006539 - Thrombotic, Inflammatory & Gene Markers of CVD in Women N/A
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

External Links