A Survey on Efficacy and Safety in Patients With Endometriosis

• Status: Completed
• Trial end date: 2017-10-13
• Target enrollment: 0
• Participant gender: Female

Summary

This survey is intended to collect efficacy and safety data of Duphaston® Tablets in patients with endometriosis under actual condition of its use and to obtain data for effectively and safely utilizing this drug.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mylan Inc.
• Treatments: Dydrogesterone

Criteria

Inclusion Criteria:

• Women aged 20 to < 50 years

• Subjects with a chocolate cyst of the ovary measuring 3 cm in diameter on transvaginal ultrasonography at patient enrollment

• Subjects with a menstrual cycle of 25 to 38 days who ovulate and are confirmed to have normal menstruation at patient enrollment

Exclusion Criteria:

• Subjects who used GnRH agonists within 6 months before patient enrollment

• Subjects who utilized hormone preparations containing corpus luteum hormone or estrogen as an active ingredient, low-dose contraceptive pills, middle-dose contraceptive pills, testosterone derivatives, or herbal products indicated for endometriosis within 3 months before patient enrollment

• Subjects who received surgical treatment for endometriosis such as transvaginal alcohol fixation, laparotomy or laparoscopic surgery within 2 months before patient enrollment

• Subjects who are pregnant or may possibly be pregnant at patient enrollment

• Subjects who are in breast feeding at patient enrollment

• Subjects who are determined by the investigator/subinvestigator to be not suitable for the subjects of the survey because of other reasons

• Subjects with liver disorder or liver disease

• Subjects with known hypersensitivity to the active substance or to any of the excipients

• Subjects with known or suspected progestogen dependent neoplasms (e.g. meningioma)

• Subjects with undiagnosed vaginal bleeding

• Subjects with a past or current history of heart or kidney disease

• Subjects with porphyria

• Subjects with depression

• Subjects with abnormal liver function values caused by acute or chronic liver disease

• Subjects with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption