A Survey on Efficacy and Safety in Patients With Endometriosis

NCT02921763 | Completed Results

• 1 other identifier: DUPKST16002
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 15

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (4)

• Change in the Volume of Ovarian Chocolate Cyst (If There Are Two or More Cysts, a Total Volume)

  In measurement of ovarian chocolate cyst, on a section visualizing the maximum diameter, two radial directions, namely the maximum diameter (D1) and maximum diameter (D2) orthogonal to D1, will be measured. A chocolate cyst of the ovary will be deemed as a spheroid, and its volume will be calculated using the following formula: \[(D1 + D2) × 1/2\]3 × 0.52 (π = 3.1). If there are two or more chocolate cysts of the ovary, similarly, two radial directions (D1 and D2) of each cyst will be measured. Also, each of their volumes will be calculated in the same manner. The change rate within ±15% from the total volume measured before treatment was defined as "unchanged," and the rate out of this range was defined as "decreased" or "increased."

  Before treatment initiation (baseline), 3 months, and 5 months.

• Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume)

  In measurement of ovarian chocolate cyst, on a section visualizing the maximum diameter, two radial directions, namely the maximum diameter (D1) and maximum diameter (D2) orthogonal to D1, will be measured. A chocolate cyst of the ovary will be deemed as a spheroid, and its volume will be calculated using the following formula: \[(D1 + D2) × 1/2\]3 × 0.52 (π = 3.1). If there are two or more chocolate cysts of the ovary, similarly, two radial directions (D1 and D2) of each cyst will be measured. Also, each of their volumes will be calculated in the same manner.

  Before treatment initiation (baseline), 3 months, and 5 months.

• Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume), Absolute Change From Baseline

  The absolute change from baseline were calculated on an individual basis and these were totalled and means ± SD calculated. For the mean value of the absolute changes shown here, the mean value of the absolute changes of the cases that could be measured at each time point is calculated. In other words, of the 57 cases with the volume value of baseline, Cycle 3 calculates the mean value of the absolute change in 39 cases with the volume value at this time, and Cycle 5 calculates the mean value of the absolute change in 40 cases with the volume value at this time. The remaining 18 cases are excluded from this calculation because there is no volume value for Cycle 3 and the absolute change from baseline cannot be calculated. The same applies to the 17 cases of Cycle 5. For this reason, these values cannot be calculated directly from the volume mean value at each time point shown in the result measurement 2.

  Before treatment initiation (baseline), 3 months, and 5 months.

• Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume), % Change From Baseline

  The % change from baseline were calculated on an individual basis and these were totalled and means ± SD calculated. For the mean value of the % changes shown here, the mean value of the % changes of the cases that could be measured at each time point is calculated. In other words, of the 57 cases with the volume value of baseline, Cycle 3 calculates the mean value of the % change in 39 cases with the volume value at this time, and Cycle 5 calculates the mean value of the % change in 40 cases with the volume value at this time. The remaining 18 cases are excluded from this calculation because there is no volume value for Cycle 3 and the % change from baseline cannot be calculated. The same applies to the 17 cases of Cycle 5. For this reason, these values cannot be calculated directly from the volume mean value at each time point shown in the result measurement 2.

  Before treatment initiation (baseline), 3 months, and 5 months.

Secondary Outcomes (8)

• Change Over Time in Dysmenorrhea Score (Total of the Dysmenorrhea Severity Score and the Analgesic Use Score)

  Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.

• Change Over Time in Visual Analogue Scale (VAS) for Dysmenorrhea

  Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.

• Change in Serum CA125

  Baseline, and 5 months.

• Change Over Time in Dysmenorrhea Score (Total of the Dysmenorrhea Severity Score and the Analgesic Use Score), Difference From Baseline

  Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.

• Change Over Time in Visual Analogue Scale (VAS) for Dysmenorrhea, Difference From Baseline

  Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.

Study Arms (1)

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.

Drug: Dydrogesterone

Interventions

Dydrogesterone DRUG

Also known as: Duphaston

Dydrogesterone

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The subjects of the survey will be patients with a diagnosis of endometriosis.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mylan Inc.: lead

Study Sites (15)

Mylan Investigational Site G

Tokyo, Chiyodaku, 101-0062, Japan

Location

Mylan Investigational Site N

Tokyo, Chuouku, 104-8560, Japan

Location

Mylan Investigational Site C

Kyoto, Fushimiku, 612-0064, Japan

Location

Mylan Investigational Site D

Saitama, Iwatsukiku, 339-0057, Japan

Location

Mylan Investigational Site M

Okayama, Kurashikishi, 710-0824, Japan

Location

Mylan Investigational Site H

Kyoto, Kyotanabeshi, 610-0357, Japan

Location

Mylan Investigational Site A

Kamigyō-ku, Kyoto, 602-8566, Japan

Location

Mylan Investigational Site I

Kyoto, Nakagyoku, 604-0965, Japan

Location

Mylan Investigational Site K

Kyoto, Nakagyoku, 604-8381, Japan

Location

Mylan Investigational Site F

Kyoto, Nakagyoku, 604-8453, Japan

Location

Mylan Investigational Site J

Tokyo, Shibuyaku, 151-0051, Japan

Location

Mylan Investigational Site B

Bunkyō, Tokyo, 113-8655, Japan

Location

Mylan Investigational Site E

Kyoto, Ukyouku, 615-0883, Japan

Location

Mylan Investigational Site L

Kyoto, Yosanocho, 629-2261, Japan

Location

Mylan Investigational Site O

Tokushima, 770-8503, Japan

Location

Related Publications (1)

• 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.

  PMID: 34262403 DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Dydrogesterone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Takumi Kanzo
• Organization: Mylan EPD G.K.

takumi.kanzo@viatris.com

+81-3-5656-0516

Study Officials

• Jo Kitawaki, MD., PhD.

  Kyoto Prefectural University of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: October 3, 2016
• Study Start: August 23, 2016
• Primary Completion: September 21, 2017
• Study Completion: October 13, 2017
• Last Updated: July 6, 2022
• Results First Posted: June 13, 2022

Record last verified: 2022-06

Locations

JP (15)