Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants
Completed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT04978688
- Run by
- Myovant Sciences GmbH
- People needed
- 48
- Starts
- 2016-06-16
- Expected to finish
- 2016-09-21
- Last updated by the study team
- 2021-07-27
Who can join
Age: 18 and older, up to 48. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Clinical Study Site — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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