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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04978688
• Other study ID #: MVT-601-1001
• Status: Completed
• Phase: Phase 1
• Start date: June 16, 2016
• Est. completion date: September 21, 2016

Study information

• Verified date: July 2021
• Source: Myovant Sciences GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 21, 2016
• Est. primary completion date: September 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Relugolix
Administered as an oral tablet once daily.
• E2/NETA
Administered as an oral tablet once daily.

Locations

Country	Name	City	State
United States	Clinical Study Site	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Myovant Sciences GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	PK: Maximum Concentration (Cmax) Of Relugolix, E2, El, NETA		Predose and up to 24 hours at Weeks 3 and 6
Primary	PK: Time To Maximum Concentration (Tmax) Of Relugolix, E2, El, EE, NETA		Predose and up to 24 hours at Weeks 3 and 6
Secondary	Change From Baseline In Serum Follicle Stimulating Hormone (FSH) At Week 6		Baseline, Week 6
Secondary	Change From Baseline In Serum Luteinizing Hormone (LH) At Week 6		Baseline, Week 6
Secondary	Change From Baseline In Serum Progesterone (P) At Week 6		Baseline, Week 6
Secondary	Change From Baseline In Serum E2 And E1 At Week 6		Baseline, Week 6
Secondary	Change From Baseline In N-telopeptide And C-telopepetide Concentrations At Week 6		Baseline, Week 6
Secondary	Incidence Of Treatment-Emergent Adverse Events		8 weeks
Secondary	Incidence Of Hot Flush		8 weeks