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E2/NETA

Phase 1

Undisclosed | Small molecule | Other |Roivant Sciences Ltd.|Trials Updated: Jul 27, 2021

E2/NETA development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

E2/NETA clinical trials

E2/NETA · 1 trial · 1 indication

Phase 1 1
NCT04978688Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female ParticipantsHealthy
COMPLETED48 Analytics
PHASE1COMPLETED
Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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
Change From Baseline In Serum Progesterone (P) At Week 6
Baseline, Week 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RelugolixEXPERIMENTALParticipants received relugolix 40 milligrams (mg) alone for 6 weeks.
Relugolix + E2/NETAEXPERIMENTALParticipants received relugolix 40 mg and E2/NETA at 1 mg/ 0.5 mg for 6 weeks.

Interventions

NameTypeDescription
RelugolixDRUGAdministered as an oral tablet once daily.
E2/NETADRUGAdministered as an oral tablet once daily.
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Eligibility Criteria

Age Range18 Years to 48 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Pre-menopausal female between 18 and 48 years of age. 2. E2, P, LH and FSH concentrations within 0.5x of the lower limits of normal range and 2x of the upper limits of normal upper limits of normal range (ULN) 3. Regular menstrual periods for the 3 months prior to study enrol...

Countries:United States
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Frequently asked questions about E2/NETA

What is E2/NETA?

E2/NETA is an investigational small molecule therapeutic being developed by Roivant Sciences Ltd. (ticker: ROIV). It has completed a Phase 1 clinical trial in healthy premenopausal female participants. The specific indications for which E2/NETA is being developed have not been disclosed.

Who is developing E2/NETA?

E2/NETA is being developed by Roivant Sciences Ltd., which trades under the ticker symbol ROIV. The company has completed a Phase 1 trial of the drug.

What phase is E2/NETA in?

E2/NETA is in Phase 1 of clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug has not been approved by the FDA and remains investigational.

What clinical trials is E2/NETA in?

E2/NETA has been evaluated in one completed Phase 1 trial, NCT04978688, titled "Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants." The trial enrolled 48 healthy premenopausal female participants in the United States and was controlled and randomized.

Is E2/NETA FDA approved?

No, E2/NETA is not FDA approved. It is an investigational small molecule in Phase 1 clinical development, with one completed Phase 1 trial. Approval status has not been granted for any indication.