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

Myovant Sciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: E2/NETA; Drug: Relugolix

Study type: Interventional

Funder types: Industry

Identifiers

NCT04978688

MVT-601-1001

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Relugolix

Experimental group

Description:

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

Treatment:

Drug: Relugolix

Relugolix + E2/NETA

Experimental group

Description:

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

Treatment:

Drug: E2/NETA

Drug: Relugolix