HealthyPhase 1NCT04978688
Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants
A Phase 1 study testing Relugolix and E2/NETA in people with Healthy, run by Myovant Sciences GmbH at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Relugolix and E2/NETA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2016to 21 Sep 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Relugolix, E2/NETA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RelugolixDrug
Administered as an oral tablet once daily.
E2/NETADrug
Administered as an oral tablet once daily.
| Study group | Role | What they receive |
|---|---|---|
| Relugolix | Experimental | Participants received relugolix 40 milligrams (mg) alone for 6 weeks. Receives: Drug: Relugolix |
| Relugolix + E2/NETA | Experimental | Participants received relugolix 40 mg and E2/NETA at 1 mg/ 0.5 mg for 6 weeks. Receives: Drug: Relugolix; Drug: E2/NETA |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK: Area Under The Concentration-Time Curve From Time Zero To Hour 24 (AUC0-24) Of Relugolix, E2, Estrone (El), Ethinylestradiol (EE), NETA
Measured: Predose and up to 24 hours at Weeks 3 and 6
PK: Maximum Concentration (Cmax) Of Relugolix, E2, El, NETA
Measured: Predose and up to 24 hours at Weeks 3 and 6
PK: Time To Maximum Concentration (Tmax) Of Relugolix, E2, El, EE, NETA
Measured: Predose and up to 24 hours at Weeks 3 and 6
Secondary outcomes (7)
Change From Baseline In Serum Follicle Stimulating Hormone (FSH) At Week 6
Measured: Baseline, Week 6
Change From Baseline In Serum Luteinizing Hormone (LH) At Week 6
Measured: Baseline, Week 6
Change From Baseline In Serum Progesterone (P) At Week 6
Measured: Baseline, Week 6
Change From Baseline In Serum E2 And E1 At Week 6
Measured: Baseline, Week 6
Change From Baseline In N-telopeptide And C-telopepetide Concentrations At Week 6
Measured: Baseline, Week 6
Incidence Of Treatment-Emergent Adverse Events
Measured: 8 weeks
Incidence Of Hot Flush
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start16 Jun 2016
- Primary completion21 Sep 2016
- Study completion21 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myovant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978688
- Sponsor's protocol ID
- MVT-601-1001
- Status last verified
- Jul 2021
- First submitted
- 20 Jul 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 37365436
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04978688
- Acronym / sponsor ID
- MVT-601-1001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Myovant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2016 (actual)
- Primary completion
- 21 Sep 2016 (actual)
- Study completion
- 21 Sep 2016 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relugolix | Experimental | Drug: RelugolixParticipants received relugolix 40 milligrams (mg) alone for 6 weeks. |
| Relugolix + E2/NETA | Experimental | Drug: Relugolix, Drug: E2/NETAParticipants received relugolix 40 mg and E2/NETA at 1 mg/ 0.5 mg for 6 weeks. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RelugolixAdministered as an oral tablet once daily. | Drug | Relugolix, Relugolix + E2/NETA |
| E2/NETAAdministered as an oral tablet once daily. | Drug | Relugolix + E2/NETA |
Primary outcome
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
PK: Maximum Concentration (Cmax) Of Relugolix, E2, El, NETA
Time frame: Predose and up to 24 hours at Weeks 3 and 6
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
7 secondary outcomes
Change From Baseline In Serum Follicle Stimulating Hormone (FSH) At Week 6
Time frame: Baseline, Week 6
Change From Baseline In Serum Luteinizing Hormone (LH) At Week 6
Time frame: Baseline, Week 6
Change From Baseline In Serum Progesterone (P) At Week 6
Time frame: Baseline, Week 6
Change From Baseline In Serum E2 And E1 At Week 6
Time frame: Baseline, Week 6
Change From Baseline In N-telopeptide And C-telopepetide Concentrations At Week 6
Time frame: Baseline, Week 6
Incidence Of Treatment-Emergent Adverse Events
Time frame: 8 weeks
Incidence Of Hot Flush
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Derived from this study: PubMed 37365436Lukes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Relugolix and E2/NETA in people with Healthy, run by Myovant Sciences GmbH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04978688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021; AzTrials last refreshed its copy on 7 Nov 2026.