Efficacy and Tolerability of Angeliq in Thai Women
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00185328
First received: September 12, 2005
Last updated: December 11, 2008
Last verified: December 2008
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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:
Drug Information available for:
Estradiol
Estradiol cypionate
Estradiol valerate
Estradiol acetate
Estradiol hemihydrate
U.S. FDA Resources
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 (Adult, Senior) |
| 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
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:
| 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 Polyestradiol phosphate Estradiol 3-benzoate Estradiol 17 beta-cypionate Estradiol valerate Drospirenone and ethinyl estradiol combination Estrogens |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female |
ClinicalTrials.gov processed this record on September 28, 2016