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

NCT ID: NCT04978688

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-16
• Study Completion Date: 2016-09-21

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Relugolix

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

Group Type: EXPERIMENTAL

Relugolix

Intervention Type: DRUG

Administered as an oral tablet once daily.

Relugolix + E2/NETA

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

Group Type: EXPERIMENTAL

Relugolix

Intervention Type: DRUG

Administered as an oral tablet once daily.

E2/NETA

Intervention Type: DRUG

Administered as an oral tablet once daily.

Interventions

Relugolix

Administered as an oral tablet once daily.

Intervention Type: DRUG

E2/NETA

Administered as an oral tablet once daily.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Myovant Sciences GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Study Site

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37365436 (View on PubMed)

Other Identifiers

MVT-601-1001

Identifier Type: -

Identifier Source: org_study_id