drugset / Trial / NCT03654274
SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the long-term efficacy and safety of relugolix 40 milligram (mg) once daily co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) for up to 104 weeks on endometriosis-associated pain in participants who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3101 or MVT-601-3102).
Timeline
- Start
- 2018-05-22
- Primary completion
- 2021-12-16
- Completion
- 2023-01-31
Publications
- As-Sanie S, Abrao MS, Reznichenko G, Wilk K, Zhong Y, Perry J, Hunsche E, Soulban G, Becker CM. Impact of relugolix combination therapy on functioning and quality of life in women with endometriosis-associated pain. Fertil Steril. 2024 Oct;122(4):687-695. doi: 10.1016/j.fertnstert.2024.06.009. Epub 2024 Jun 19.
- Becker CM, Johnson NP, As-Sanie S, Arjona Ferreira JC, Abrao MS, Wilk K, Imm SJ, Mathur V, Perry JS, Wagman RB, Giudice LC. Two-year efficacy and safety of relugolix combination therapy in women with endometriosis-associated pain: SPIRIT open-label extension study. Hum Reprod. 2024 Mar 1;39(3):526-537. doi: 10.1093/humrep/dead263.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol/norethindrone acetate | Unknown | 0.5 mg | Oral |
| Subject | Estradiol/norethindrone acetate | Unknown | 1 mg | Oral |
| Subject | Relugolix | Small molecule | 40 mg | Oral |