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

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: EE20/DRSP(YAZ, BAY86-5300) Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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:

MedlinePlus related topics: Menstruation

Drug Information available for: Ethinyl Estradiol Drospirenone

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

The difference in DRSP scale scores for the 3 functional impairment items, comparing the average over the last 5 days of daily scores from the 3rd cycle in the treatment phase to the average of daily scores from the 2 run in cycles [ Time Frame: 3 cycles ] [ Designated as safety issue: No ]
Descriptive statistics for total DRSP scale scores (sum of the first 21 items) of the last 5 days for each of the 2 run in cycles, each of the 3 cycles in the treatment phase, and the average of the 3 cycles in the treatment phase [ Time Frame: 3 cylces ] [ Designated as safety issue: No ]
Descriptive statistics for change in total DRSP scale scores (sum of the first 21 items) of the last 5 days from baseline to each cycle in the treatment phase and to the average of the 3 cycles in the treatment phase [ Time Frame: 3 cycles ] [ 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 ]

Enrollment:	187
Study Start Date:	January 2009
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: EE20/DRSP(YAZ, BAY86-5300) 20 μg ethinylestradiol, 3mg drospirenone, tablet, orally, opd
Placebo Comparator: Arm 2	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 Premenstrual Syndrome (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

Locations

China, Guangdong

Guangzhou, Guangdong, China, 510405

Guangzhou, Guangdong, China, 510630
China, Hubei

Wuhan, Hubei, China, 430060
China, Hunan

Changsha, Hunan, China, 410011
China, Jiangsu

Nanjing, Jiangsu, China, 210029
China, Liaoning

Dalian, Liaoning, China, 116011
China, Shandong

Jinan, Shandong, China, 250012
China, Shanxi

Xi'an, Shanxi, China, 710032

Xi'an, Shanxi, China, 710061
China, Sichuan

Chengdu, Sichuan, China, 610041
China, Yunnan

Kunming, Yunnan, China, 650032
China, Zhejiang

Hangzhou, Zhejiang, China, 310003
China

Beijing, China, 100191

Beijing, China, 100050

Beijing, China, 100853

Tianjin, China, 300193

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

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT00824187 History of Changes
Other Study ID Numbers:	91771, 311962
Study First Received:	January 15, 2009
Last Updated:	March 21, 2013
Health Authority:	China: State Food and Drug Administration (SFDA)

Keywords provided by Bayer:

Premenstrual Dysphoric Disorder ( PMDD)
Oral contraceptive

Additional relevant MeSH terms:

Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes
Contraceptive Agents
Contraceptives, Oral
Ethinyl Estradiol
Drospirenone
Drospirenone and ethinyl estradiol combination
Reproductive Control Agents

Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Aldosterone Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on May 16, 2013