NCT04978688

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2016

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

July 20, 2021

Last Update Submit

July 20, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (7)

  • 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

  • Change From Baseline In Serum E2 And E1 At Week 6

    Baseline, Week 6

  • Change From Baseline In N-telopeptide And C-telopepetide Concentrations At Week 6

    Baseline, Week 6

  • +2 more secondary outcomes

Study Arms (2)

Relugolix

EXPERIMENTAL

Participants received relugolix 40 milligrams (mg) alone for 6 weeks.

Drug: Relugolix

Relugolix + E2/NETA

EXPERIMENTAL

Participants received relugolix 40 mg and E2/NETA at 1 mg/ 0.5 mg for 6 weeks.

Drug: RelugolixDrug: E2/NETA

Interventions

RelugolixDRUG

Administered as an oral tablet once daily.

RelugolixRelugolix + E2/NETA
E2/NETADRUG

Administered as an oral tablet once daily.

Relugolix + E2/NETA

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pre-menopausal female between 18 and 48 years of age.
  • 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)
  • Regular menstrual periods for the 3 months prior to study enrollment
  • Body weight ≥ 45 killograms (kgs) and body mass index (BMI) of 20 to 36
  • Capable of giving written informed consent

You may not qualify if:

  • Pregnancy
  • Lactating Females
  • Any contraindication to the treatment with E2 and NETA
  • Use of the following medications in the 3 months prior to screening: injectable hormonal contraceptives, sex hormone medications or danazol
  • Use of the following medications in the 6 months prior to screening: injectable gonadotropin-releasing hormone agonists, hormonal, or non-hormonal intrauterine devices
  • History of sensitivity to any of the study medications of components thereof or history of drug
  • Significant gynecological, endocrine, metabolic or other health conditions
  • History of regular alcohol consumption within 6 months of study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Study Site

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (1)

  • Lukes A, Migoya E, Johnson B, Lee TY, Li Y, Arjona Ferreira JC. A Randomized Open-Label Study of Relugolix Alone or Relugolix Combination Therapy in Premenopausal Women. Clin Pharmacokinet. 2023 Aug;62(8):1169-1182. doi: 10.1007/s40262-023-01269-9. Epub 2023 Jun 26.

    PMID: 37365436DERIVED

MeSH Terms

Interventions

relugolix

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2021

First Posted

July 27, 2021

Study Start

June 16, 2016

Primary Completion

September 21, 2016

Study Completion

September 21, 2016

Last Updated

July 27, 2021

Record last verified: 2021-07

Locations

US(1)