NCT04978688 is a Phase 1 clinical trial of Relugolix in Healthy, sponsored by Myovant Sciences GmbH.

Who is sponsoring NCT04978688?

NCT04978688 is sponsored by Myovant Sciences GmbH.

What drugs are being tested in NCT04978688?

Interventions in NCT04978688: Relugolix, E2/NETA.

Is NCT04978688 still recruiting?

NCT04978688 is currently completed. Last updated 27 July 2021.

Last reviewed 2021-07-27 · How we verify

NCT04978688

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants

Completed Phase 1 Last updated 27 July 2021

What this trial tests

Phase 1 trial testing Relugolix in Healthy in 48 participants. Completed in 21 September 2016.

Timeline

16 June 2016

Primary endpoint
21 September 2016

21 September 2016

Quick facts

Lead sponsor	Myovant Sciences GmbH
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	16 June 2016
Primary completion	21 September 2016
Estimated completion	21 September 2016
Sites	1 location across United States

Drugs / interventions tested

Relugolix (relugolix) — full drug profile →
E2/NETA

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Myovant Sciences GmbH — full company profile →

Who can join

Adults 18 to 48, female only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

A Randomized Open-Label Study of Relugolix Alone or Relugolix Combination Therapy in Premenopausal Women.
Lukes A, Migoya E, Johnson B, Lee TY, et al · · 2023 · cited 10× · PMID 37365436 · DOI 10.1007/s40262-023-01269-9
An evaluation of relugolix/estradiol/norethindrone acetate for the treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Ali M, Chen HY, Chiang YF, Badary OA, et al · · 2022 · cited 8× · PMID 35068291 · DOI 10.1080/14656566.2022.2030705

Verify or expand the search:

Other trials of Relugolix

Trials testing the same drug.

NCT07025369 — Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With H · Phase 2 · recruiting
NCT06650579 — REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial · Phase 3 · recruiting
NCT06463457 — Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED) · Phase 2 · active not recruiting
NCT06499870 — Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OP · Phase 2 · recruiting
NCT06330805 — Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer · Phase 2 · recruiting

Other recruiting trials for Healthy

Currently open trials in the same condition.

NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other Myovant Sciences GmbH trials

Trials by the same sponsor.

NCT04714554 — A Study of the Effects of Erythromycin on the Pharmacokinetics of Relugolix, Estradiol, and Norethindrone in Healthy Pos · Phase 1 · completed
NCT03751124 — Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uteri · Phase 3 · completed
NCT03744507 — Bone Mineral Density in Women With Uterine Fibroids or Endometriosis · completed
NCT03654274 — SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain · Phase 3 · completed
NCT03204318 — SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04978688 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Myovant Sciences GmbH
Last refreshed: 27 July 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04978688.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing