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Completed

NCT Number: NCT04978688

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

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.

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Key information

Conditions

Healthy

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Study Site

Minneapolis, Minnesota, 55404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pre-menopausal female between 18 and 48 years of age.
  • 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)
  • Regular menstrual periods for the 3 months prior to study enrollment
  • Body weight ≥ 45 killograms (kgs) and body mass index (BMI) of 20 to 36
  • Capable of giving written informed consent

Exclusion criteria

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

Treatment and study plan

Relugolix

Drug

Administered as an oral tablet once daily.

E2/NETA

Drug

Administered as an oral tablet once daily.

Primary outcomes

  1. PK: Area Under The Concentration-Time Curve From Time Zero To Hour 24 (AUC0-24) Of Relugolix, E2, Estrone (El), Ethinylestradiol (EE), NETA

    Time frame: Predose and up to 24 hours at Weeks 3 and 6

  2. PK: Maximum Concentration (Cmax) Of Relugolix, E2, El, NETA

    Time frame: Predose and up to 24 hours at Weeks 3 and 6

  3. PK: Time To Maximum Concentration (Tmax) Of Relugolix, E2, El, EE, NETA

    Time frame: Predose and up to 24 hours at Weeks 3 and 6

Secondary outcomes

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

    Time frame: Baseline, Week 6

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

    Time frame: Baseline, Week 6

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

    Time frame: Baseline, Week 6

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

    Time frame: Baseline, Week 6

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

    Time frame: Baseline, Week 6

  6. Incidence Of Treatment-Emergent Adverse Events

    Time frame: 8 weeks

  7. Incidence Of Hot Flush

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Myovant Sciences GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 27, 2021
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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