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YAZ Premenstrual Dysphoric Disorder (PMDD) in China

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Premenstrual Dysphoric Disorder ( PMDD)

Intervention: EE20/DRSP(YAZ, BAY86-5300) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

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).

Clinical Details

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)

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

Primary outcome: 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

Secondary outcome:

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

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

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

Assessment of CGI scores

Adverse events

Laboratory tests

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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

Locations and Contacts

Beijing 100050, China

Beijing 100191, China

Beijing 100853, China

Tianjin 300193, China

Guangzhou, Guangdong 510405, China

Guangzhou, Guangdong 510630, China

Wuhan, Hubei 430060, China

Changsha, Hunan 410011, China

Nanjing, Jiangsu 210029, China

Dalian, Liaoning 116011, China

Jinan, Shandong 250012, China

Xi'an, Shanxi 710032, China

Xi'an, Shanxi 710061, China

Chengdu, Sichuan 610041, China

Kunming, Yunnan 650032, China

Hangzhou, Zhejiang 310003, China

Additional Information

Click here and search for drug information provided by the FDA.

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

Starting date: January 2009
Last updated: April 1, 2014

Page last updated: August 23, 2015

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