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

• Sponsor: Myovant Sciences GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04978688
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.2
• Patients Per Site Per Month: 15.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Relugolix; Drug: E2/NETA	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 16, 2016
• Actual Primary Completion Date: Sep 21, 2016
• Actual Study Completion Date: Sep 21, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Relugolix Participants received relugolix 40 milligrams (mg) alone for 6 weeks.	Drug: Relugolix; Administered as an oral tablet once daily.
Experimental: Relugolix + E2/NETA Participants received relugolix 40 mg and E2/NETA at 1 mg/ 0.5 mg for 6 weeks.	Drug: Relugolix; Administered as an oral tablet once daily.; Drug: E2/NETA; Administered as an oral tablet once daily.

Outcome Measures

Primary Outcome Measures

1. 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]

2. PK: Maximum Concentration (Cmax) Of Relugolix, E2, El, NETA [Predose and up to 24 hours at Weeks 3 and 6]

3. PK: Time To Maximum Concentration (Tmax) Of Relugolix, E2, El, EE, NETA [Predose and up to 24 hours at Weeks 3 and 6]

Secondary Outcome Measures

1. Change From Baseline In Serum Follicle Stimulating Hormone (FSH) At Week 6 [Baseline, Week 6]

2. Change From Baseline In Serum Luteinizing Hormone (LH) At Week 6 [Baseline, Week 6]

3. Change From Baseline In Serum Progesterone (P) At Week 6 [Baseline, Week 6]

4. Change From Baseline In Serum E2 And E1 At Week 6 [Baseline, Week 6]

5. Change From Baseline In N-telopeptide And C-telopepetide Concentrations At Week 6 [Baseline, Week 6]

6. Incidence Of Treatment-Emergent Adverse Events [8 weeks]

7. Incidence Of Hot Flush [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 48 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Study Site	Minneapolis	Minnesota	United States	55404

Sponsors and Collaborators

• Myovant Sciences GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Myovant Sciences GmbH
• ClinicalTrials.gov Identifier: NCT04978688
• Other Study ID Numbers: MVT-601-1001
• First Posted: Jul 27, 2021
• Last Update Posted: Jul 27, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Relugolix

Study Results

No Results Posted as of Jul 27, 2021