Clinical trial NCT02921763: A Survey on Efficacy and Safety in Patients With Endometriosis
Official title: Duphaston® Tablets 5 mg - A Survey on Efficacy and Safety in Patients With Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects of the survey will be patients with a diagnosis of endometriosis.

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.

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

Primary outcomes:
measure: Change in the Volume of Ovarian Chocolate Cyst (If There Are Two or More Cysts, a Total Volume)
timeFrame: Before treatment initiation (baseline), 3 months, and 5 months.
measure: Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume)
timeFrame: Before treatment initiation (baseline), 3 months, and 5 months.
measure: Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume), Absolute Change From Baseline
timeFrame: Before treatment initiation (baseline), 3 months, and 5 months.
measure: Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume), % Change From Baseline
timeFrame: Before treatment initiation (baseline), 3 months, and 5 months.
Secondary outcomes:
measure: Change Over Time in Dysmenorrhea Score (Total of the Dysmenorrhea Severity Score and the Analgesic Use Score)
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.
measure: Change Over Time in Visual Analogue Scale (VAS) for Dysmenorrhea
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.
measure: Change in Serum CA125
timeFrame: Baseline, and 5 months.
measure: Change Over Time in Dysmenorrhea Score (Total of the Dysmenorrhea Severity Score and the Analgesic Use Score), Difference From Baseline
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.
measure: Change Over Time in Visual Analogue Scale (VAS) for Dysmenorrhea, Difference From Baseline
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.
measure: Change Over Time in Visual Analogue Scale (VAS) for Dysmenorrhea, Change Rate From Baseline (%)
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.
measure: Change in Serum CA125, Difference From Baseline
timeFrame: Baseline, and 5 months.
measure: Change in Serum CA125, Change Rate From Baseline (%)
timeFrame: Baseline, and 5 months.
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Mylan Investigational Site G
state: Chiyodaku
city: Tokyo
country: Japan
facility: Mylan Investigational Site N
state: Chuouku
city: Kyoto
country: Japan
facility: Mylan Investigational Site C
state: Fushimiku
city: Saitama
country: Japan
facility: Mylan Investigational Site D
state: Iwatsukiku
city: Okayama
country: Japan
facility: Mylan Investigational Site M
state: Kurashikishi
city: Kyoto
country: Japan
facility: Mylan Investigational Site H
state: Kyotanabeshi
city: Kamigyo-ku
country: Japan
facility: Mylan Investigational Site A
state: Kyoto
city: Kyoto
country: Japan
facility: Mylan Investigational Site I
state: Nakagyoku
city: Kyoto
country: Japan
facility: Mylan Investigational Site K
state: Nakagyoku
city: Kyoto
country: Japan
facility: Mylan Investigational Site F
state: Nakagyoku
city: Tokyo
country: Japan
facility: Mylan Investigational Site J
state: Shibuyaku
city: Bunkyō
country: Japan
facility: Mylan Investigational Site B
state: Tokyo
city: Kyoto
country: Japan
facility: Mylan Investigational Site E
state: Ukyouku
city: Kyoto
country: Japan
facility: Mylan Investigational Site L
state: Yosanocho
city: Tokushima
country: Japan
facility: Mylan Investigational Site O
Study officials:
affiliation: Kyoto Prefectural University of Medicine
name: Jo Kitawaki, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.