Clinical trial NCT04978688: Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants
Official title: A Randomized Open Label Study to Evaluate the Safety, PK, and PD of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy for 6 Weeks in Healthy Premenopausal Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Myovant Sciences GmbH
Sponsor class: INDUSTRY
First posted: 2021-07-27
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 enrollment
4. Body weight ≥ 45 killograms (kgs) and body mass index (BMI) of 20 to 36
5. Capable of giving written informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: PK: Area Under The Concentration-Time Curve From Time Zero To Hour 24 (AUC0-24) Of Relugolix, E2, Estrone (El), Ethinylestradiol (EE), NETA
timeFrame: Predose and up to 24 hours at Weeks 3 and 6
measure: PK: Maximum Concentration (Cmax) Of Relugolix, E2, El, NETA
timeFrame: Predose and up to 24 hours at Weeks 3 and 6
measure: PK: Time To Maximum Concentration (Tmax) Of Relugolix, E2, El, EE, NETA
timeFrame: Predose and up to 24 hours at Weeks 3 and 6
Secondary outcomes:
measure: Change From Baseline In Serum Follicle Stimulating Hormone (FSH) At Week 6
timeFrame: Baseline, Week 6
measure: Change From Baseline In Serum Luteinizing Hormone (LH) At Week 6
timeFrame: Baseline, Week 6
measure: Change From Baseline In Serum Progesterone (P) At Week 6
timeFrame: Baseline, Week 6
measure: Change From Baseline In Serum E2 And E1 At Week 6
timeFrame: Baseline, Week 6
measure: Change From Baseline In N-telopeptide And C-telopepetide Concentrations At Week 6
timeFrame: Baseline, Week 6
measure: Incidence Of Treatment-Emergent Adverse Events
timeFrame: 8 weeks
measure: Incidence Of Hot Flush
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Clinical Study Site
state: Minnesota
Study officials:
References: