Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Estradiol/norethindrone · 7 trials · 6 indications
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding. The sustained responder rate was calculated as the Kaplan-Meier estimate of the cumulative probability of MBL volume \< 80 mL through Week 76 using the Kaplan-Meier method.
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for dysmenorrhea declined from baseline to Week 52 by at least 2.8 points without increased use of protocol-specified analgesics for pelvic pain at Week 52 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for NMPP declined from baseline to Week 52 by at least 2.1 points without increased use of protocol-specified analgesics for pelvic pain at Week 52 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for dysmenorrhea declined from baseline to Week 104 by at least 2.8 points without increased use of protocol-specified analgesics for pelvic pain at Week 104 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for NMPP declined from baseline to Week 104 by at least 2.1 points without increased use of protocol-specified analgesics for pelvic pain at Week 104 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Assessed using a Numerical Rating Scale (NRS) score (11-point scale) for pain recorded daily in an electronic diary (e-Diary). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary. The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
A responder was a participant who had MBL volume of \< 80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of treatment (up to Week 52). All returned feminine products collected at each clinical visit were analyzed by the alkaline hematin method to obtain the MBL volume. MBL volume was measured over the Week 52/early termination feminine product collection interval (up to 35 days prior to the last dose of treatment). The percentage of participants who were responders are presented.
A responder was a participant who had MBL volume of \< 80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of treatment (up to Week 24). All returned feminine products collected at each clinical visit were analyzed by the alkaline hematin method to obtain the MBL volume. MBL volume was measured over the Week 24/early termination feminine product collection interval (up to 35 days prior to the last dose of treatment). The percentage of participants who were responders are presented. As per the objective of the study, the pre-specified primary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| Arm | Type | Description |
|---|---|---|
| Relugolix plus E2/NETA | EXPERIMENTAL | Relugolix 40 mg co-administered with estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 52 weeks. |
| Placebo tablets and capsules | PLACEBO_COMPARATOR | * Placebo for relugolix co-administered with placebo for E2/NETA for up to 52 weeks or until heavy menstrual bleeding returns. * Retreatment with open-label relugolix with E2/NETA will be offered if heavy menstrual bleeding returns. |
| Relugolix plus E2/NETA (Group A) | EXPERIMENTAL | Relugolix co-administered with E2/NETA for 24 weeks. |
| Relugolix plus Delayed E2/NETA (Group B) | EXPERIMENTAL | Relugolix co-administered with E2/NETA placebo for 12 weeks, followed by relugolix co-administered with E2/NETA for 12 weeks. |
| Placebo (Group C) | PLACEBO_COMPARATOR | Relugolix placebo co-administered with E2/NETA placebo for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| Relugolix | DRUG | Relugolix 40 mg tablet administered orally once daily |
| Estradiol/norethindrone acetate | DRUG | Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily |
| Placebo for relugolix | DRUG | Placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor |
| Placebo for E2/NETA | DRUG | Placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor |
| Estradiol/norethindrone acetate placebo | DRUG | E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor. |
| Relugolix placebo | DRUG | Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor. |
Inclusion Criteria: 1. Completed the open-label extension study (MVT-601-3003). 2. Is a responder: Has a menstrual blood loss of \< 80 mL AND at least a 50% reduction from the parent study Baseline based on the results of the alkaline hematin testing performed on the feminine products returned at t...
Estradiol/norethindrone is an investigational combination being studied for endometriosis related pain, heavy menstrual bleeding, uterine leiomyoma, and endometriosis. It is in Phase 3 clinical development as a small molecule therapy for these endocrine-related conditions in women.
Estradiol/norethindrone is being developed by Roivant Sciences Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker ROIV. The company is conducting Phase 3 clinical trials to evaluate this combination therapy for gynecological conditions.
Estradiol/norethindrone is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 3 trials have been completed, with three studies enrolling a total of 1,261 women.
Estradiol/norethindrone has been studied in three completed Phase 3 trials: NCT03103087 (LIBERTY 2) for heavy menstrual bleeding with uterine fibroids, NCT03204318 (SPIRIT 1) for endometriosis-associated pain, and NCT03204331 (SPIRIT 2) for endometriosis-associated pain. A fourth trial, NCT03751124, also studied the combination in uterine fibroids.
Estradiol/norethindrone is a component of combination therapy studied alongside relugolix. The clinical trials listed for Estradiol/norethindrone include studies of relugolix combined with estradiol and norethindrone acetate, such as NCT03751124. The drug is not the same as relugolix alone.