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Efficacy and Safety Study in Postmenopausal Women to Determine the Lowest Effective Dose for Relief of Moderate to Severe Hot-Flushes
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00206622
First received: September 12, 2005
Last updated: May 28, 2009
Last verified: May 2009
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Purpose
To determine the lowest effective dose of estradiol by comparing E2/LNG (2.2mg/0.69mg) and E2 (1.0mg) dose with placebo in decreasing the frequency and severity of moderate to severe hot flushes in postmenopausal women
| Condition | Intervention | Phase |
|---|---|---|
| Hot Flashes | Drug: Climara PRO (Estradiol / Levonorgestrel transdermal) Drug: Menostar (Estradiol transdermal) Drug: Placebo transdermal | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Comparing a 2.2mg 17 Beta-Estradiol/0.69mg Levonorgestrel Combination Transdermal Patch, and a 1mg 17 Beta-Estradiol Transdermal Patch With a Placebo Patch in Postmenopausal Women to Determine the Lowest Effective Dose of Estradiol for the Relief of Moderate to Severe Hot Flushes |
Resource links provided by NLM:
Drug Information available for:
Estradiol
Estradiol cypionate
Levonorgestrel
Estradiol valerate
Estradiol acetate
Estradiol hemihydrate
U.S. FDA Resources
Further study details as provided by Bayer:
Primary Outcome Measures:
- Lowest effective dose in decreasing the frequency and severity of hot flushes
Secondary Outcome Measures:
- Other symptoms related to menopause
| Enrollment: | 425 |
| Study Start Date: | December 2004 |
| Study Completion Date: | February 2006 |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Arm 1 |
Drug: Climara PRO (Estradiol / Levonorgestrel transdermal)
2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch
|
| Active Comparator: Arm 2 |
Drug: Menostar (Estradiol transdermal)
1mg 17 Beta-estradiol transdermal patch
|
| Placebo Comparator: Arm 3 |
Drug: Placebo transdermal
Placebo
|
Detailed Description:
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.
Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
Eligibility| Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Menopause
- Reporting a minimum of 7 moderate to severe hot flushes per day for at least 1 week (7 consecutive days), or a minimum of 50 moderate to severe hot flushes per week for at least 1 week (7 consecutive days)
Exclusion Criteria:
- Hormonal treatment
- Contraindication to estrogen/progestogen therapy
Contacts and Locations
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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: NCT00206622
Show 45 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206622
Show 45 Study Locations
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Therapeutic Area Head, Bayer HealthCare Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00206622 History of Changes |
| Other Study ID Numbers: |
91429 308261 |
| Study First Received: | September 12, 2005 |
| Last Updated: | May 28, 2009 |
Additional relevant MeSH terms:
|
Hot Flashes Signs and Symptoms Estradiol Polyestradiol phosphate Estradiol 3-benzoate Estradiol 17 beta-cypionate Estradiol valerate Levonorgestrel Estrogens |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female Contraceptives, Oral, Synthetic Contraceptives, Oral |
ClinicalTrials.gov processed this record on June 27, 2017