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E2/NETA

Phase 1

Healthy | Small molecule | Other |Roivant Sciences Ltd.|Last Updated: Jul 27, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

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
Healthy
NCT0497868848
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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 being developed by Roivant Sciences Ltd. (ticker: ROIV). It is currently in Phase 1 clinical development. The drug is being studied in healthy premenopausal female participants as part of a combination hormonal add-back therapy.

What is E2/NETA used for?

E2/NETA is being studied for use in healthy premenopausal female participants. It is being evaluated in combination with relugolix in a Phase 1 clinical trial. The study aims to assess the effects of relugolix alone and combined with hormonal add-back therapy in this healthy population.

Who makes E2/NETA?

E2/NETA is being developed by Roivant Sciences Ltd., a biopharmaceutical company traded under the ticker ROIV. The company is conducting clinical trials to evaluate the drug's safety and effects in healthy premenopausal female participants.

What phase is E2/NETA in?

E2/NETA is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a completed Phase 1 trial involving healthy premenopausal female participants.

What clinical trials is E2/NETA in?

E2/NETA is associated with one completed Phase 1 clinical trial, NCT04978688, titled 'Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants.' The trial enrolled 48 participants in the United States and was a randomized, controlled study.

Is E2/NETA the same as relugolix?

No, E2/NETA is not the same as relugolix. In the clinical trial NCT04978688, E2/NETA is being studied as a hormonal add-back therapy combined with relugolix. The trial compares relugolix alone versus relugolix combined with E2/NETA in healthy premenopausal female participants.