YAZ Premenstrual Dysphoric Disorder (PMDD) in China - Full Text View

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)

Resource links provided by NLM:

Drug Information available for: Ethinyl estradiol

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

The primary efficacy variable is the difference in DRSP scale scores for the first 21 items, comparing average scores from the last 5 days of the 3rd treatment cycle to average scores from the last 5 days of the 2 run in cycles [ Time Frame: 3 cycles (1 cycle= 28 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Descriptive statistics for total DRSP scale scores for each of the 2 run cycles, each of the 3 treatment cycles, and the average of the 3 treatment cycles [ Time Frame: 3 cycles ] [ Designated as safety issue: No ]
Difference in DRSP scale scores for the 3 functional impairment items, comparing the average of daily scores from the 3rd treatment cycle to the average of daily scores from the 2 run in cycles [ Time Frame: 3 cylces ] [ Designated as safety issue: No ]
Assessment of CGI scores [ Time Frame: 3 cycles ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: Whole study period ] [ Designated as safety issue: Yes ]
Laboratory tests [ Time Frame: Whole study period ] [ Designated as safety issue: Yes ]

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

Criteria

Inclusion Criteria:

Chinese women of reproductive age 18-45 years (inclusive) with a diagnosis of Premenstrual Dysphoric Disorder (PMDD)

Exclusion Criteria:

Any formal psychotherapeutic counselling within 1 month before the screening visit (Visit 1) or used medication for PMS or Premenstrual Dysphoric Disorder (PMDD) including, but not limited to hormones, bromocriptine, GnRH agonists, vitamin B6 (>100 mg), calcium supplements (> 1500 mg/day), anxiolytics, and antidepressants during the 3 month period prior to Visit 1
Use of sleeping medication (including melatonin) for more than 3 days per month.
Pregnancy or less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment
Obesity (body mass index or BMI > 30 kg/m2)
Hypersensitivity to any ingredient of the study drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824187

Contacts

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

Locations

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

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

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)

Keywords provided by Bayer:

Premenstrual Dysphoric Disorder ( PMDD)
Oral contraceptive

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 08, 2010