Trial Condition(s):
Phase 3 study of dienogest for the treatment of endometriosis in Chinese patients
13390
Not Available
Not Available
This study is aimed to evaluate efficacy and safety of dienogest 2 mg oral tablets in the treatment of endometriosis.
There will be 2 study phases: a double-blind, randomized, placebo-controlled, parallel-group phase over 24 weeks, and an open-label extension phase with 2 mg DNG daily p.o. over 28 weeks for all subjects who completed the double-blind phase, irrespective of their treatment assignment in the first study phase.
- Women between 18 and 45 years of age, inclusive - Women with endometriosis confirmed by laparoscopy or laparotomy within ten years but no later than 2 weeks before the Screening Visit - A score of at least 30 on a 100 mm visual analog scale (VAS) for endometriosis-associated pelvic pain at Screening Visit and Baseline Visit - Good general health (except for findings related to endometriosis, with or without infertility), as evidenced by medical history and complete physical and gynecological examination - Willingness to use a barrier method of contraception is required
- Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment) - Wish for pregnancy within intended treatment period - Before menarche or after menopause - Amenorrhea (more than three consecutive months in the six months before screening) - Undiagnosed abnormal genital bleeding - Previous/use of hormonal agents - Any disease or condition that may worsen under hormonal treatment - Signs and/or symptoms of therapy-resistant endometriosis despite more than one prior attempt at drug treatment or surgical therapy - Need for primary surgical treatment of endometriosis - Regular use of pain medication due to other underlying diseases - Contra-indication for the supportive analgesic medication (ibuprofen)
Locations | Status | |
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Locations Investigative Site Beijing, China, 100730 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100191 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100038 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100029 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Changchun, China, 130021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shijiazhuang, China, 050000 | 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 Kunming, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hengyang, China, 421001 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wuhan, China, 430030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chengdu, China, 610072 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100034 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chongqing, China, 400016 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100026 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200127 | 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 Chongqing, China, 400042 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chongqing, China, 400010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100044 | Status Terminated | 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 |
Locations Investigative Site Guangzhou, China, 510120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shenyang, China, 110004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hangzhou, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
A multicenter study to investigate the efficacy and safety of daily oral administration of 2 mg dienogest tablets (Visanne/SH T00660AA) for the treatment of endometriosis in Chinese patients: a double-blind, randomized, placebo-controlled, parallel group phase over 24 weeks followed by an open-label, single-group follow up over 28 weeks
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2