Efficacy and Tolerability of Angeliq in Thai Women
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ClinicalTrials.gov Identifier: NCT00185328 |
Recruitment Status :
Completed
First Posted : September 16, 2005
Last Update Posted : December 12, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postmenopause | Drug: Estradiol/DRSP (Angeliq, BAY86-4891) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 55 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | September 2005 |
Actual Study Completion Date : | December 2006 |

Arm | Intervention/treatment |
---|---|
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 |
- The relative change in the frequency of hot flushes [ Time Frame: At baseline, week 4, 8, 12 ]
- 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 ]

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Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Postmenopausal women with hot flushes
Exclusion Criteria:
- Women with a contraindication for Hormone Replacement Therapy (HRT)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185328
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Medical Affairs Therapeutic Area Head, Bayer Schering Pharma AG |
ClinicalTrials.gov Identifier: | NCT00185328 |
Other Study ID Numbers: |
91436 309367 |
First Posted: | September 16, 2005 Key Record Dates |
Last Update Posted: | December 12, 2008 |
Last Verified: | December 2008 |
Postmenopause |
Estradiol Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |