Status:
COMPLETED
Phase 3 Study of Dienogest for the Treatment of Endometriosis in Chinese Patients
Lead Sponsor:
Bayer
Conditions:
Endometriosis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
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, par...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT01822080
Start Date
March 1 2013
End Date
November 1 2015
Last Update
November 25 2015
Active Locations (26)
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1
Guangzhou, Guangdong, China, 510120
2
Shijiazhuang, Hebei, China, 050000
3
Wuhan, Hubei, China, 430030
4
Hengyang, Hunan, China, 421001