Trial Condition(s):
YAZ Premenstrual Dysphoric Disorder (PMDD) in China
91771
Not Available
Not Available
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).
- Chinese women of reproductive age 18-45 years (inclusive) with a diagnosis of Premenstrual Dysphoric Disorder (PMDD)
- 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 | Status | |
---|---|---|
Locations Investigative Site Guangzhou, China, 510630 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guangzhou, China, 510405 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100853 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jinan, China, 250012 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100050 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100191 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Changsha, China, 410011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wuhan, China, 430060 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Xi'an, China, 710061 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kunming, China, 650032 | Status Completed | Contact Us: E-mail: [email protected]healthcare.com Phone: Not Available |
Locations Investigative Site Nanjing, China, 210029 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hangzhou, China, 310003 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Xi'an, China, 710032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tianjin, China, 300193 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dalian, China, 116011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chengdu, China, 610041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2