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| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00824187 |
Purpose
The purpose of this study is to evaluate the efficacy and safety of YAZ compared to placebo in the treatment of symptoms related to Premenstrual Dysphoric Disorder (PMDD).
| Condition | Intervention | Phase |
|---|---|---|
|
Premenstrual Dysphoric Disorder ( PMDD) |
Drug: YAZ (SH T00186, BAY86-5300) Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Monophasic Oral Contraceptive YAZ (20 µg Ethinylestradiol, 3 mg Drospirenone) in the Treatment of Chinese Patients With Premenstrual Dysphoric Disorder (PMDD) |
| Estimated Enrollment: | 186 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Arm 1: Experimental |
Drug: YAZ (SH T00186, BAY86-5300)
20 μg ethinylestradiol, 3mg drospirenone, tablet, orally, opd
|
| Arm 2: Placebo Comparator |
Drug: Placebo
Inert tablet
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com | |
| Contact: For trial location information (Phone Menu Options '3' or '4') | (+)1-888-84 22937 |
| China | |
| Recruiting | |
| Beijing, China, 100083 | |
| Recruiting | |
| Tianjin, China, 300193 | |
| Recruiting | |
| Beijing, China, 100853 | |
| Recruiting | |
| Beijing, China, 100050 | |
| China, Guangdong | |
| Recruiting | |
| Guangzhou, Guangdong, China, 510630 | |
| Recruiting | |
| Guangzhou,, Guangdong, China, 510405 | |
| China, Hubei | |
| Recruiting | |
| Wuhan, Hubei, China, 430060 | |
| China, Hunan | |
| Recruiting | |
| Changsha, Hunan, China, 410013 | |
| China, Jiangsu | |
| Recruiting | |
| Nanjing, Jiangsu, China, 210029 | |
| China, Liaoning | |
| Recruiting | |
| Dalian, Liaoning, China, 116011 | |
| China, Shandong | |
| Recruiting | |
| Jinan, Shandong, China, 250012 | |
| China, Shanxi | |
| Recruiting | |
| Xi'an, Shanxi, China, 710061 | |
| Recruiting | |
| Xi'an, Shanxi, China, 710032 | |
| China, Sichuan | |
| Recruiting | |
| Chengdu, Sichuan, China, 610041 | |
| China, Yunnan | |
| Recruiting | |
| Kunming, Yunnan, China, 650032 | |
| China, Zhejiang | |
| Recruiting | |
| Hangzhou, Zhejiang, China, 310003 | |
| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Bayer Schering Pharma AG ( Therapeutic Area Head ) |
| Study ID Numbers: | 91771, 311962 |
| Study First Received: | January 15, 2009 |
| Last Updated: | February 5, 2010 |
| ClinicalTrials.gov Identifier: | NCT00824187 History of Changes |
| Health Authority: | China: State Food and Drug Administration (SFDA) |
|
Premenstrual Dysphoric Disorder ( PMDD) Oral contraceptive |
|
Estrogens Disease Contraceptive Agents Contraceptives, Oral Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Ethinyl Estradiol Reproductive Control Agents |
Depressive Disorder Hormones Pharmacologic Actions Pathologic Processes Menstruation Disturbances Mental Disorders Therapeutic Uses Mood Disorders Premenstrual Syndrome |