A Survey on Efficacy and Safety in Patients With Endometriosis

NCT ID: NCT02921763

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-23
• Study Completion Date: 2017-10-13

Brief 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.

Detailed Description

In Japan, Duphaston® Tablets have appeared in 1965 for the treatment of endometriosis and been used at some medical institutions. However, after releasing of danazol in the early 1980's and gonadotropin-releasing hormone (GnRH) agonists in the late 1980's, pseudomenopause therapy became mainstream because of its high efficacy. However, pseudopregnancy therapy was recognized again due to adverse reactions associated with pseudomenopause therapy. After 2000, low-dose estrogen/progestin (LEP) combination drugs (as LEP products, ethinylestradiol/norethisterone combination drug and ethinylestradiol/drospirenone combination drug) and dienogest have been utilized as drugs that are safer and can be administered for a long time. In recent years, Duphaston® Tablets are increasing recognized again from the viewpoints of its efficacy and safety because the drug has no effect to inhibit ovulation or effect on basal body temperature, a diagnosis of ovulation and other conditions may be made by following up basal body temperature, and pregnancy may be achieved even during treatment with Duphaston. As previously mentioned, Duphaston® Tablets are an old drug, and there are only few clinical data from Japanese patients; thus, its latest clinical efficacy and safety data are being demanded again mainly by obstetrician-gynecologists.

Conditions

Endometriosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Dydrogesterone

Dydrogesterone 20 mg (4 tablets) per day should be orally administered in 2 divided doses (in the morning and evening). It should be administered for 21 days; dosage starts on the 5th day of each menstrual cycle until 25th day. The administration period will be from the start of Duphaston treatment (cycle 1) to cycle 4.

Dydrogesterone

Intervention Type: DRUG

Interventions

Dydrogesterone

Intervention Type: DRUG

Other Intervention Names

Duphaston

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mylan Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jo Kitawaki, MD., PhD.

Role: PRINCIPAL_INVESTIGATOR

Kyoto Prefectural University of Medicine

Locations

Mylan Investigational Site G

Tokyo, Chiyodaku, Japan

Mylan Investigational Site N

Tokyo, Chuouku, Japan

Mylan Investigational Site C

Kyoto, Fushimiku, Japan

Mylan Investigational Site D

Saitama, Iwatsukiku, Japan

Mylan Investigational Site M

Okayama, Kurashikishi, Japan

Mylan Investigational Site H

Kyoto, Kyotanabeshi, Japan

Mylan Investigational Site A

Kamigyō-ku, Kyoto, Japan

Mylan Investigational Site I

Kyoto, Nakagyoku, Japan

Mylan Investigational Site K

Kyoto, Nakagyoku, Japan

Mylan Investigational Site F

Kyoto, Nakagyoku, Japan

Mylan Investigational Site J

Tokyo, Shibuyaku, Japan

Mylan Investigational Site B

Bunkyō, Tokyo, Japan

Mylan Investigational Site E

Kyoto, Ukyouku, Japan

Mylan Investigational Site L

Kyoto, Yosanocho, Japan

Mylan Investigational Site O

Tokushima, , Japan

Countries

Japan

References

Kitawaki J, Koga K, Kanzo T, Momoeda M. An assessment of the efficacy and safety of dydrogesterone in women with ovarian endometrioma: An open-label multicenter clinical study. Reprod Med Biol. 2021 Jun 4;20(3):345-351. doi: 10.1002/rmb2.12391. eCollection 2021 Jul.

Reference Type: DERIVED

PMID: 34262403 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

DUPKST16002

Identifier Type: -

Identifier Source: org_study_id