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This study is designed to provide direct evidence on the relative effectiveness and safety of Elagolix versus OCPs, helping physicians make more tailored treatment decisions.
Eligible patients will be assigned to one of two groups: Elagolix 150 mg once daily or OCPs daily, based on physician recommendation and patient preference. Baseline demographic and clinical information will be recorded. Pain outcomes (dysmenorrhea, dyspareunia, non menstrual pain) will be assessed on the NRS at baseline, 12 weeks, and 24 weeks. Adverse events will be documented throughout.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elagolix Group | Experimental | 45 participants in Elagolix group. Elagolix will be administered at 150 mg once daily in this study. |
|
| OCPs group | Experimental | 45 Participants in this group. OCPs will be administered once daily in a continuous 28-day cycles for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elagolix | Drug | Elagolix will be administered at 150 mg once daily in this study. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score (Reduction in Pain) | Primary outcomes will focus on patient-reported levels of dysmenorrhea, non-menstrual pelvic pain and dyspareunia. Each primary outcome will be evaluated by using numerical pain scale (NRS), ranging from 0 (no pain) to 10 (worst pain). These pain scores are scheduled to be recorded at baseline (week 0), mid-treatment (week 12) and at end of treatment (week 24). Any adverse events occurring during this duration will also be documented. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria
Females will be included
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pak Emirates Military Hospital | Rawalpindi | Punjab Province | Pakistan |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D004194 | Disease |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C539351 | elagolix |
| D003276 | Contraceptives, Oral |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
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| Oral Contraceptive (OC) |
| Drug |
In this study, administered once daily in a continuous 28-day cycles for 3 months |
|
| D000091662 | Genital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |