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ContraceptionPhase 3SERENENCT04756037

Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy

A Phase 3 study testing Relugolix Combination Therapy in people with Contraception, run by Sumitomo Pharma Switzerland GmbH at 112 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the contraceptive efficacy of relugolix combination therapy. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Contraception
What is being tested?
Relugolix Combination Therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,164 participants
Where
112 sitesin 2 countries
Study dates
18 Mar 2021to 31 Mar 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Is a premenopausal woman, 18 to 50 years of age.
  • Is at risk of pregnancy (that is, having heterosexual intercourse at least once per month) and is seeking contraception.
  • Has normal, regular menstrual cycles that are between 21 and 35 days in duration.
  • Has a diagnosis of uterine fibroids or endometriosis meeting either of the following criteria:
  • Diagnosis of uterine fibroids by confirmation of ultrasound performed in the last 2 years and patient report of heavy menstrual bleeding affecting quality of life.
  • Diagnosis of endometriosis and has had surgical or direct visualization (laparoscopy or laparotomy) and/or histopathologic confirmation of endometriosis, and the patient reports moderate, severe, or very severe pain during the most recent menses and/or during nonmenstrual portion of the cycle in the prior month
  • Is willing to use the study intervention as the sole method of contraception for 13 consecutive 28-day treatment cycles and does not intend to use any other form of contraception (for example, condoms).

Who cannot join

  • Is pregnant, or breastfeeding, or has breastfed in the last year.
  • Has a known history of infertility or sub-fertility.
  • Has presence or history of a venous thromboembolic event (for example, deep vein thrombosis, pulmonary embolism), an arterial thrombotic or thromboembolic event (for example, myocardial infarction, stroke, or peripheral arterial), or a transient ischemic attack, angina pectoris, or claudication.
  • Has a higher risk of arterial, venous thrombotic, or thromboembolic disorders.
  • Has a history of migraine with aura or focal neurological symptoms.
  • Has uncontrolled hypertension, diabetes with inadequate control, or multiple cardiovascular risk factors.
Show all 17Show fewer
  • Has a history of clinically significant ventricular arrhythmias.
  • Has clinically significant liver disease, including active viral hepatitis or cirrhosis.
  • Has a history of pancreatitis associated with severe hypertriglyceridemia.
  • Has known human immunodeficiency virus (HIV) infection or high risk of contracting HIV.
  • Has a hepatic hemangioma or has a history of cholestasis with prior estrogen use or during pregnancy.
  • Has a serious contraindication to pregnancy (for example, a medical condition or use of chronic medication such as isotretinoin or thalidomide).
  • History of suicidal ideation or behavior, or confirmed "yes" to any question (with exception of non-suicidal self-injurious behavior, unless deemed as an unacceptable risk by the investigator) on the C-SSRS.
  • Has a bone mineral density Z-score ≤ -2.0 at lumbar spine, femoral neck, or total hip during the screening period.
  • Has a history of or currently has osteoporosis, or other metabolic bone disease, collagen vascular disease, chronic kidney disease (CKD) stage 3 or greater with glomerular filtration rate (GFR) < 60 mL/min/m2 using Modification of Diet in Renal Disease (MDRD) method, hyperparathyroidism, hyperprolactinemia, known pituitary adenoma, hyperthyroidism, anorexia nervosa, abnormal bone mineral metabolism (eg, hypophosphatemia), or low traumatic (fragility) fracture.
  • Has used chronic glucocorticoids that are oral, parenteral, inhaled (prednisone equivalents of ≥ 2.5 mg daily for ≥ 3 months) in 12 months prior to the study.
  • Has known BRCA mutation or other mutation associated with increased risk of breast cancer.

Trial locations and contacts

112 sites in 2 countries.

112 sites in 2 countries

United States109 sites

  • Albuquerque

    Albuquerque, New Mexico, 87109

  • Annandale

    Annandale, Virginia, 22003

  • Atlanta

    Atlanta, Georgia, 30328

  • Atlanta

    Atlanta, Georgia, 30363

  • Aurora

    Aurora, Colorado, 80045

  • Austin

    Austin, Texas, 78705

  • Aventura

    Aventura, Florida, 33180

  • Baltimore

    Baltimore, Maryland, 21237

  • Beaumont

    Beaumont, Texas, 77702

  • Bellevue

    Bellevue, Washington, 98007

  • Boynton Beach

    Boynton Beach, Florida, 33435

  • Brownsburg

    Brownsburg, Indiana, 46112

  • Burbank

    Burbank, California, 91506

  • Canoga Park

    Canoga Park, California, 91303

  • Chandler

    Chandler, Arizona, 85224

  • Chattanooga

    Chattanooga, Tennessee, 37404

  • Cherry Hill

    Cherry Hill, New Jersey, 08034

  • Chicago

    Chicago, Illinois, 60607

  • Chicago

    Chicago, Illinois, 60611

  • College Park

    College Park, Georgia, 30349

  • Columbus

    Columbus, Georgia, 31909

  • Columbus

    Columbus, Ohio, 43210

  • Columbus

    Columbus, Ohio, 43213

  • Columbus

    Columbus, Ohio, 43231

  • Covington

    Covington, Louisiana, 70433

  • Dallas

    Dallas, Texas, 75230

  • Davie

    Davie, Florida, 33024

  • Dearborn Heights

    Dearborn Heights, Michigan, 48127

  • Deland

    DeLand, Florida, 32720

  • Detroit

    Detroit, Michigan, 48201

  • Durham

    Durham, North Carolina, 27713

  • Encinitas

    Encinitas, California, 92024

  • Fairfield

    Fairfield, Ohio, 45014

  • Fort Worth

    Fort Worth, Texas, 76104

  • Franklin

    Franklin, Ohio, 45005

  • Gardena

    Gardena, California, 90247

  • Greenwood Village

    Greenwood Village, Colorado, 80111

  • Hialeah

    Hialeah, Florida, 33016

  • Houston

    Houston, Texas, 77021

  • Houston

    Houston, Texas, 77024

  • Houston

    Houston, Texas, 77054

  • Jackson

    Jackson, Mississippi, 39202

  • Jacksonville

    Jacksonville, Florida, 32256

  • Kissimmee

    Kissimmee, Florida, 34741

  • Lake Worth

    Lake Worth, Florida, 33461

  • Lancaster

    Lancaster, California, 93534

  • Las Vegas

    Las Vegas, Nevada, 89106

  • Las Vegas

    Las Vegas, Nevada, 89109

  • League City

    League City, Texas, 77573

  • Long Beach

    Long Beach, California, 90805

  • Long Beach

    Long Beach, California, 90806

  • Loxahatchee

    Loxahatchee Groves, Florida, 33470

  • Margate

    Margate, Florida, 33063

  • Marrero

    Marrero, Louisiana, 70072

  • Memphis

    Memphis, Tennessee, 38120

  • Meridian

    Meridian, Idaho, 83646

  • Mesa

    Mesa, Arizona, 85209

  • Metairie

    Metairie, Louisiana, 70001

  • Miami

    Miami, Florida, 33126

  • Miami

    Miami, Florida, 33140

  • Miami

    Miami, Florida, 33155

  • Miami

    Miami, Florida, 33173

  • Minot

    Minot, North Dakota, 58701

  • Mishawaka

    Mishawaka, Indiana, 46545

  • Mobile

    Mobile, Alabama, 36604

  • Myrtle Beach

    Myrtle Beach, South Carolina, 29572

  • Nampa

    Nampa, Idaho, 83687

  • New Bern

    New Bern, North Carolina, 28562

  • New Orleans

    New Orleans, Louisiana, 70127

  • New Port Richey

    New Port Richey, Florida, 34652

  • New York

    New York, New York, 10029

  • Norcross

    Norcross, Georgia, 30093

  • Norfolk

    Norfolk, Virginia, 23502

  • North Las Vegas

    North Las Vegas, Nevada, 89030

  • Orlando

    Orlando, Florida, 32808

  • Orlando

    Orlando, Florida, 32822

  • Palo Alto

    Palo Alto, California, 94304

  • Panama City

    Panama City, Florida, 32405

  • Pearland

    Pearland, Texas, 77584

  • Peoria

    Peoria, Arizona, 85381

  • Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Philadelphia

    Philadelphia, Pennsylvania, 19114

  • Phoenix

    Phoenix, Arizona, 85020

  • Portland

    Portland, Oregon, 97239

  • Raleigh

    Raleigh, North Carolina, 27607

  • Raleigh

    Raleigh, North Carolina, 27612

  • Sacramento

    Sacramento, California, 95817

  • Saginaw

    Saginaw, Michigan, 48602

  • Salt Lake City

    Salt Lake City, Utah, 84107

  • San Antonio

    San Antonio, Texas, 78233

  • San Antonio

    San Antonio, Texas, 78258

  • San Diego

    San Diego, California, 92111

  • San Fernando

    San Fernando, California, 91340

  • Sandy Springs

    Sandy Springs, Georgia, 30328

  • Sarasota

    Sarasota, Florida, 34239

  • Savannah

    Savannah, Georgia, 31406

  • Seattle

    Seattle, Washington, 98105

  • Shawnee

    Shawnee, Kansas, 66218

  • Shreveport

    Shreveport, Louisiana, 71118

  • Smyrna

    Smyrna, Georgia, 30082

  • Saint Louis

    St Louis, Missouri, 63108

  • Saint Louis

    St Louis, Missouri, 63141

  • Summerville

    Summerville, South Carolina, 29485

  • Towson

    Towson, Maryland, 21204

  • Valley Village

    Valley Village, California, 91607

  • Washington

    Washington D.C., District of Columbia, 20011

  • Washington

    Washington D.C., District of Columbia, 20036

  • West Covina

    West Covina, California, 91790

  • Winston-Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

Puerto Rico3 sites

  • Cidra

    Cidra, 00739

  • San Juan

    San Juan, 00907

  • San Juan

    San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Single-Arm, Open-Label Study to Evaluate the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are 18 to 50 Years of Age and at Risk for Pregnancy

The purpose of this study is to assess the contraceptive efficacy of relugolix combination therapy.

Read the detailed description

This is a single-arm, open-label, phase 3 study to assess the contraceptive efficacy of relugolix combination therapy (relugolix 40 milligrams [mg], estradiol [E2] 1 mg, and norethindrone acetate [NETA] 0.5 mg).

Conditions
Contraception
Being tested
Relugolix Combination Therapy
Keywords
Relugolix, Estradiol, Norethindrone acetate, Uterine Fibroids, Endometriosis
Medical subject headings
Leiomyoma, Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Relugolix Combination TherapyDrug

    Also called Myfembree

    Participants will receive orally 1 fixed-dose combination tablet (relugolix 40 mg/E2 1 mg/NETA 0.5 mg) once daily.

Study groups in NCT04756037
Study groupRoleWhat they receive
Relugolix/E2/NETAExperimentalParticipants will receive relugolix combination therapy for 1 year (13 consecutive 28-day treatment cycles).
Receives: Drug: Relugolix Combination Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the At-Risk Pearl Index (PI)

    The At-Risk PI is defined as the number of on treatment pregnancies per 100 women-years of treatment. The At-Risk PI will be calculated on the basis of cycles considered at-risk of pregnancy, that is, consecutive 28-day periods without use of any other contraceptive methods and with affirmed occurrence of vaginal intercourse. On-treatment pregnancies are pregnancies with an estimated conception date between the first day of study intervention intake up to and including 7 days after the last intake of study medication.

    Measured: 13 consecutive 28-day treatment cycles

Secondary outcomes (6)

  1. Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the Modified At-Risk PI

    The Modified At-Risk PI is based on the number of on-treatment pregnancies occurring during cycles without any other contraceptive methods, regardless of occurrence of vaginal intercourse. On-treatment pregnancies are pregnancies with an estimated conception date between the first day of study intervention intake up to and including 7 days after the last intake of study medication.

    Measured: 13 consecutive 28-day treatment cycles

  2. Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the Gross PI

    The "typical use" contraceptive efficacy will be assessed using the Gross PI, based on the number of on-treatment pregnancies occurring during all cycles regardless of the use of other contraceptive methods, confirmed vaginal intercourse, or protocol compliance. On-treatment pregnancies are pregnancies with an estimated conception date between the first day of study intervention intake up to and including 7 days after the last intake of study medication.

    Measured: 13 consecutive 28-day treatment cycles

  3. Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the Method Failure PI

    The "perfect use" contraceptive efficacy will be assessed using the Method Failure PI, based on the number of on-treatment pregnancies occurring during cycles that are at risk and without major protocol deviations. On-treatment pregnancies are pregnancies with an estimated conception date between the first day of study intervention intake up to and including 7 days after the last intake of study medication.

    Measured: 13 consecutive 28-day treatment cycles

  4. Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the Cumulative 1-Year Pregnancy Rates

    Cumulative 1-year pregnancy rate and the associated 95% CI will be estimated on each of the efficacy analysis populations by the Kaplan-Meier (KM) survival analysis.

    Measured: 13 consecutive 28-day treatment cycles

  5. Number of Participants Who Do Not Complete 13 Treatment Cycles

    Proportion of enrolled participants who do not complete 13 treatment cycles. Treatment cycle is defined as consecutive 28-day period

    Measured: 13 consecutive 28-day treatment cycles

  6. Percent Change in Bone Mineral Density From Baseline to 6 and 12 Months On-Treatment

    The percent change in bone mineral density will be measured from baseline to 6- and 12-months on treatment at the lumbar spine (L1-L4), total hip, and femoral neck.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2021
  2. Study start18 Mar 2021
  3. Primary completion25 Feb 2025
  4. Study completion31 Mar 2026

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04756037
Sponsor's protocol ID
MVT-601-050
Acronym
SERENE
Status last verified
May 2026
First submitted
12 Feb 2021
Last updated
13 May 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Neblett MF 2nd, Stewart EA. Oral Gonadotropin-Releasing Hormone Antagonists for the Treatment of Uterine Leiomyomas. Obstet Gynecol. 2023 May 1;141(5):901-910. doi: 10.1097/AOG.0000000000005145. Epub 2023 Apr 5.

    PubMed 37103532

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Relugolix Combination Therapy in people with Contraception, run by Sumitomo Pharma Switzerland GmbH at 112 sites in 2 countries.

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 7 inclusion and 17 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 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the At-Risk Pearl Index (PI) (time frame: 13 consecutive 28-day treatment cycles). 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 NCT04756037, 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 13 May 2026.

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