N/A
Completed N=60
A Survey on Efficacy and Safety in Patients With Endometriosis
Source: ClinicalTrials.gov NCT02921763 ↗Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Jun 2022
Primary outcomePrimary: Change in the Volume of Ovarian Chocolate Cyst (If There Are Two or More Cysts, a Total Volume) — 26; 13; 13 Participants — p==0.0533
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Volume of Ovarian Chocolate Cyst (If There Are Two or More Cysts, a Total Volume) |
26; 13; 13 | =0.0533 |
| PRIMARY Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume) |
45.76; 51.97; 60.27 | — |
| PRIMARY Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume), Absolute Change From Baseline |
0.04; 8.48 | =0.7328 |
| PRIMARY Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume), % Change From Baseline |
3.97; -6.40 | 0.7221 |
| SECONDARY Change Over Time in Dysmenorrhea Score (Total of the Dysmenorrhea Severity Score and the Analgesic Use Score) |
2.30; 1.75; 1.31; 1.12; 1.00; 1.05 | — |
| SECONDARY Change Over Time in Visual Analogue Scale (VAS) for Dysmenorrhea |
4.33; 3.35; 2.54; 2.37; 2.03; 2.01 | — |
| SECONDARY Change in Serum CA125 |
55.66; 47.52 | — |
| SECONDARY Change Over Time in Dysmenorrhea Score (Total of the Dysmenorrhea Severity Score and the Analgesic Use Score), Difference From Baseline |
-0.54; -0.90; -1.02; -0.96; -1.00 | =0.0020 sig |
| SECONDARY Change Over Time in Visual Analogue Scale (VAS) for Dysmenorrhea, Difference From Baseline |
-0.93; -1.61; -1.98; -1.94; -1.52 | =0.0024 sig |
| SECONDARY Change Over Time in Visual Analogue Scale (VAS) for Dysmenorrhea, Change Rate From Baseline (%) |
-9.23; -33.97; -38.01; -41.24; -35.75 | =0.0037 sig |
| SECONDARY Change in Serum CA125, Difference From Baseline |
-6.47 | =0.8035 |
| SECONDARY Change in Serum CA125, Change Rate From Baseline (%) |
38 | =0.8185 |
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
Data sourced from ClinicalTrials.gov (NCT02921763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.