endometriosis or uterine fibroids endometriosis or uterine fibroids
Conditions
Interventions
Relugolix 40 mg is initiated on days 1-5 of the first menstrual cycle after enrollment and is administered daily for 2 months. If the Simplified Menopausal Index (SMI) score increases from the SMI sco
Sponsors
Izumi Gentaro
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Those who have menstruation 2. Those diagnosed with endometriosis or uterine fibroids 3. Those with symptoms associated with menstruation (dysmenorrhea, pelvic pain, or excessive menstruation) that are considered indications for the use of GnRH agonist preparations 4. Women 18 years and older and under 48 years of age at the time consent is obtained 5. Those who have received a full explanation of the study and have given written consent of their own free will based on a full understanding of the study 6. Those who can make outpatient visits in accordance with the research implementation schedule
Exclusion criteria
Exclusion criteria: 1. Postmenopausal women 2. Pregnant women or those who may be pregnant 3. Those who are breastfeeding 4. Those with submucosal myoma 5. Those with undiagnosed abnormal genital bleeding (in the presence of possible malignant disease) 6. Those with a history of hypersensitivity to the ingredients of Lergolix 7. Those using GnRH analogs during the 3 months immediately prior to the start of the study medication 8. Those Patients using sex hormone-based pharmacotherapy for endometriosis or uterine fibroids other than levonorgestrel-releasing intrauterine system (Mirena) during the month immediately preceding the start of the study drug 9. Those unable to cooperate with non-hormonal contraception during the treatment period 10. Those deemed by the principal investigator or subinvestigator to be inappropriate to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in menopausal symptoms (Simplified Menopausal Index ;SMI) from 2 to 6 months after the start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in MMAS, a measure of health-related quality of life specific to menstrual complications (baseline to 2 months, 2 months to 6 months after treatment, and 6 months after baseline) 2. Change in VAS, a measure of pelvic pain (baseline to 2 months, 2 months to 6 months after treatment, and 6 months after baseline) 3. If endometriotic ovarian cysts are present, change in their length diameter (2 months from baseline, 2 months to 6 months from start of treatment, and 6 months from baseline) 4. If uterine fibroids are present, change in top 3 longest diameters from largest to smallest (2 months from baseline, 2 months to 6 months from start of treatment, and 6 months from baseline) 5. Change in menopausal symptoms (SMI) (baseline to 2 months and baseline to 6 months) 6. Percent change in menopausal symptoms (SMI) (baseline to 2 months, 2 months to 6 months, and 6 months from baseline) 7. Change in serum estradiol level (E2) and FSH (2 months after baseline, 2 to 6 months after treatment, and 6 months after baseline) 8. Duration of experiencing abnormal bleeding (2 months after baseline, 2 to 6 months after treatment, and 6 months after baseline) | — |
Contacts
Public ContactGentaro Izumi
The University of Tokyo Hospital
Outcome results
None listed