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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
Sponsor:
Information provided by:
Bayer

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

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

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.


Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Estradiol

Arms and Interventions
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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


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

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

Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information
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Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
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Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00185328     History of Changes
Other Study ID Numbers: 91436
309367
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: December 12, 2008
Last Verified: December 2008

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