Efficacy and Tolerability of Angeliq in Thai Women

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00185328
First received: September 12, 2005
Last updated: December 11, 2008
Last verified: December 2008
  Purpose

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


Condition Intervention Phase
Postmenopause
Drug: Estradiol/DRSP (Angeliq, BAY86-4891)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • The relative change in the frequency of hot flushes [ Time Frame: At baseline, week 4, 8, 12 ]

Secondary Outcome Measures:
  • The change in intensity of hot flushes [ Time Frame: At baseline, week 4, 8, 12 ]
  • The relative change in frequency of hot flushes [ Time Frame: At baseline, week 4, 8 ]
  • The change in intensity of hot flushes [ Time Frame: At baseline, week 4, 8 ]
  • The proportions of subjects with urogenital symptoms [ Time Frame: At baseline, week 4, 8, 12 ]
  • Bleeding pattern [ Time Frame: At baseline, week 4, 8, 12 ]
  • Adverse events collection [ Time Frame: Collection of AE throughout the study period ]

Enrollment: 55
Study Start Date: September 2005
Study Completion Date: December 2006
Arms Assigned Interventions
Experimental: Arm 1 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

Detailed 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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal women with hot flushes

Exclusion Criteria:

  • Women with a contraindication for Hormone Replacement Therapy (HRT)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185328

Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00185328     History of Changes
Other Study ID Numbers: 91436, 309367
Study First Received: September 12, 2005
Last Updated: December 11, 2008
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Bayer:
Postmenopause

Additional relevant MeSH terms:
Estradiol
Drospirenone and ethinyl estradiol combination
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 29, 2014