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This was a randomized, open-label, repeat dose study of once daily relugolix alone or relugolix combined with hormonal add-back therapy (combination estradiol/norethindrone acetate) (E2/NETA) to assess safety, including markers of bone resorption, pharmacokinetics (PK), and pharmacodynamics (PD) endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relugolix | Experimental | Participants received relugolix 40 milligrams (mg) alone for 6 weeks. |
|
| Relugolix + E2/NETA | Experimental | Participants received relugolix 40 mg and E2/NETA at 1 mg/ 0.5 mg for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relugolix | Drug | Administered as an oral tablet once daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Area Under The Concentration-Time Curve From Time Zero To Hour 24 (AUC0-24) Of Relugolix, E2, Estrone (El), Ethinylestradiol (EE), NETA | Predose and up to 24 hours at Weeks 3 and 6 | |
| PK: Maximum Concentration (Cmax) Of Relugolix, E2, El, NETA | Predose and up to 24 hours at Weeks 3 and 6 | |
| PK: Time To Maximum Concentration (Tmax) Of Relugolix, E2, El, EE, NETA | Predose and up to 24 hours at Weeks 3 and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline In Serum Follicle Stimulating Hormone (FSH) At Week 6 | Baseline, Week 6 | |
| Change From Baseline In Serum Luteinizing Hormone (LH) At Week 6 | Baseline, Week 6 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Study Site | Minneapolis | Minnesota | 55404 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37365436 | Derived | Lukes A, Migoya E, Johnson B, Lee TY, Li Y, Arjona Ferreira JC. A Randomized Open-Label Study of Relugolix Alone or Relugolix Combination Therapy in Premenopausal Women. Clin Pharmacokinet. 2023 Aug;62(8):1169-1182. doi: 10.1007/s40262-023-01269-9. Epub 2023 Jun 26. |
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| ID | Term |
|---|---|
| C561634 | relugolix |
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| E2/NETA |
| Drug |
Administered as an oral tablet once daily. |
|
| Change From Baseline In Serum Progesterone (P) At Week 6 |
| Baseline, Week 6 |
| Change From Baseline In Serum E2 And E1 At Week 6 | Baseline, Week 6 |
| Change From Baseline In N-telopeptide And C-telopepetide Concentrations At Week 6 | Baseline, Week 6 |
| Incidence Of Treatment-Emergent Adverse Events | 8 weeks |
| Incidence Of Hot Flush | 8 weeks |