Efficacy and Safety Study in Postmenopausal Women to Determine the Lowest Effective Dose for Relief of Moderate to Severe Hot-Flushes
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00206622 |
Recruitment Status :
Completed
First Posted : September 21, 2005
Last Update Posted : May 29, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hot Flashes | Drug: Climara PRO (Estradiol / Levonorgestrel transdermal) Drug: Menostar (Estradiol transdermal) Drug: Placebo transdermal | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 425 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
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 |
Study Start Date : | December 2004 |
Actual Study Completion Date : | February 2006 |

Arm | Intervention/treatment |
---|---|
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 |
- Lowest effective dose in decreasing the frequency and severity of hot flushes
- Other symptoms related to menopause

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, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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): NCT00206622
United States, Alabama | |
Huntsville, Alabama, United States, 35801 | |
United States, Arizona | |
Chandler, Arizona, United States, 85225 | |
Phoenix, Arizona, United States, 85031 | |
Tucson, Arizona, United States, 85712 | |
United States, California | |
Fair Oaks, California, United States, 95628 | |
Oakland, California, United States, 94612 | |
San Diego, California, United States, 92103 | |
San Diego, California, United States, 92108 | |
San Diego, California, United States, 92123 | |
United States, Connecticut | |
New Britain, Connecticut, United States, 06050 | |
West Hartford, Connecticut, United States, 06117 | |
United States, Florida | |
Fort Myers, Florida, United States, 33916 | |
Gainesville, Florida, United States, 32610-0254 | |
Jacksonville, Florida, United States, 32216 | |
Tampa, Florida, United States, 33613 | |
West Palm Beach, Florida, United States, 33409 | |
United States, Georgia | |
Alpharetta, Georgia, United States, 30005 | |
United States, Idaho | |
Boise, Idaho, United States, 83702 | |
Idaho Falls, Idaho, United States, 83404 | |
United States, Illinois | |
Champaign, Illinois, United States, 61820 | |
Chicago, Illinois, United States, 60612 | |
Peoria, Illinois, United States, 61615 | |
United States, Indiana | |
South Bend, Indiana, United States, 46601 | |
United States, Kentucky | |
Lexington, Kentucky, United States, 40536 | |
United States, Louisiana | |
New Orleans, Louisiana, United States, 70115 | |
New Orleans, Louisiana, United States, 70118-1034 | |
United States, Michigan | |
Detroit, Michigan, United States, 48201 | |
United States, Missouri | |
St. Louis, Missouri, United States, 63110 | |
United States, Nebraska | |
Lincoln, Nebraska, United States, 68510 | |
United States, Nevada | |
Reno, Nevada, United States, 89502 | |
United States, New Jersey | |
New Brunswick, New Jersey, United States, 08901 | |
United States, New Mexico | |
Albuquerque, New Mexico, United States, 87102 | |
United States, North Carolina | |
Winston-Salem, North Carolina, United States, 27103 | |
United States, Ohio | |
Cincinnati, Ohio, United States, 45236 | |
Cleveland, Ohio, United States, 44122 | |
Columbus, Ohio, United States, 43213 | |
United States, Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19114 | |
Pittsburgh, Pennsylvania, United States, 15206 | |
United States, Tennessee | |
Memphis, Tennessee, United States, 38120 | |
United States, Texas | |
Arlington, Texas, United States, 76012 | |
Houston, Texas, United States, 77004 | |
Houston, Texas, United States, 77030 | |
Temple, Texas, United States, 76502-1896 | |
United States, Utah | |
Salt Lake City, Utah, United States, 84124 | |
United States, Vermont | |
Burlington, Vermont, United States, 05401-1420 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Therapeutic Area Head, Bayer HealthCare Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00206622 |
Other Study ID Numbers: |
91429 308261 |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | May 29, 2009 |
Last Verified: | May 2009 |
Hot Flashes Estradiol 17 beta-cypionate Estradiol 3-benzoate Levonorgestrel Estradiol Polyestradiol phosphate Estrogens Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents, Hormonal Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female Contraceptives, Oral, Synthetic Contraceptives, Oral |