Trial | NCT04978688  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    48
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.
Study Started
Jun 16
2016
Primary Completion
Sep 21
2016
Study Completion
Sep 21
2016
Last Update
Jul 27
2021

Drug Relugolix

Administered as an oral tablet once daily.

Drug E2/NETA [norethindrone, ethinyl estradiol (Estinyl)]

Administered as an oral tablet once daily.

Relugolix Experimental

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

Relugolix + E2/NETA Experimental

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

Criteria 

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
No Results Posted