Relugolix Combination Therapy for Birth Control

(SERENE Trial)

Not currently recruiting at 116 trial locations

Overseen By Myovant Medical Monitor Study Director

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: Sumitomo Pharma Switzerland GmbH

Must not be taking: Isotretinoin, Thalidomide

Disqualifiers: Pregnancy, Infertility, Thromboembolic events, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial aims to evaluate the effectiveness of a new combination therapy as a birth control method. The treatment involves taking a specific medication for one year and is intended for women with regular menstrual cycles seeking effective contraception. Participants should have experienced heavy menstrual bleeding due to uterine fibroids or significant pain from endometriosis. This trial suits those who wish to use Relugolix Combination Therapy as their sole birth control method during the study. As a Phase 3 trial, it represents the final step before potential FDA approval, offering participants the opportunity to contribute to developing a new contraceptive option.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you must use the study intervention as your only method of contraception during the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that relugolix combination therapy is generally safe. Earlier studies reported a low rate of serious side effects, with most patients tolerating it well. Some studies mention a risk of early pregnancy loss, so doctors may check for pregnancy before starting the treatment. Additionally, over 90% of patients resumed their periods within two months after stopping the treatment, indicating that any effects on menstruation are temporary. Overall, other studies have considered the treatment safe and effective. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Relugolix combination therapy is unique because it combines relugolix, a GnRH receptor antagonist, with estradiol (E2) and norethindrone acetate (NETA), offering a novel approach to hormonal birth control. Unlike standard oral contraceptives that often rely on estrogen and progestin combinations, this therapy uses relugolix to effectively and directly suppress ovarian hormone production, potentially reducing side effects associated with traditional estrogen doses. Researchers are excited because this combination could provide a more balanced hormonal control with fewer hormonal fluctuations, potentially improving tolerability and adherence.

What evidence suggests that this treatment might be an effective treatment for birth control?

Research has shown that relugolix combination therapy holds promise in treating various conditions. For instance, it has reduced menstrual and non-menstrual pain in women with endometriosis. In one study, many women experienced relief from pelvic pain compared to those who did not receive the treatment. These findings suggest that the therapy effectively manages symptoms related to hormonal conditions. Although this does not directly pertain to birth control, the positive effects on related issues are encouraging for its potential use in contraception. Participants in this trial will receive relugolix combination therapy for one year to evaluate its effectiveness as a contraceptive. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for premenopausal women aged 18-50 who are at risk of pregnancy and seeking contraception. Participants must be willing to use the study drug as their only birth control method for over a year. They should have either endometriosis confirmed by surgery or severe menstrual pain, or uterine fibroids diagnosed via ultrasound with heavy bleeding.

Inclusion Criteria

You have menstrual cycles that are regular, occurring every 21 to 35 days.

I have uterine fibroids diagnosed by ultrasound in the last 2 years and they cause me heavy menstrual bleeding.

I have been diagnosed with endometriosis, confirmed by surgery or biopsy, and I experience significant pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive relugolix combination therapy for contraceptive efficacy over 13 consecutive 28-day treatment cycles

12 months

Follow-up

Participants are monitored for safety and effectiveness, including bone mineral density changes, after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Relugolix Combination Therapy

Trial Overview The trial is testing Relugolix Combination Therapy's ability to prevent pregnancy in women with uterine fibroids or endometriosis. It will measure how effective this therapy is when used as the sole contraceptive method across multiple menstrual cycles.

How Is the Trial Designed?

Group I: Relugolix/E2/NETA Experimental Treatment 1 Intervention

Participants will receive relugolix combination therapy for 1 year (13 consecutive 28-day treatment cycles).

Who Is Running the Clinical Trial?

Sumitomo Pharma Switzerland GmbH

Lead Sponsor

Trials

19

Recruited

6,900+

Myovant Sciences GmbH

Lead Sponsor

Trials

23

Recruited

12,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10905503/

Two-year efficacy and safety of relugolix combination therapy ... For up to 2 years, treatment with relugolix CT improved menstrual and non-menstrual pain, dyspareunia, and function in women with endometriosis.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04756037

NCT04756037 | Study of the Safety and Contraceptive ... This is a single-arm, open-label, phase 3 study to assess the contraceptive efficacy of relugolix combination therapy.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12489269/

Safety and efficacy of relugolix combination therapy in ... In women treated with relugolix-CT alone, 71 (94.7%) responded after two months. By nine months, only 36 (44.4%) women continued with relugolix ...

4. clinicaltrial.be clinicaltrial.be/en/details/47506?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Study of the Safety and Contraceptive Efficacy of Relugol... This is a single-arm, open-label, phase 3 study to assess the contraceptive efficacy of relugolix combination therapy (relugolix 40 milligrams [ ...

5. thelancet.com thelancet.com/article/s0140-6736%2822%2900622-5/fulltext

Once daily oral relugolix combination therapy versus ... Women treated with relugolix combination therapy reported significant improvement in overall pelvic pain and dyspareunia compared with those who ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/relugolix-estradiol-and-norethindrone-oral-route/description/drg-20516721

Relugolix, estradiol, and norethindrone (oral route) This medicine may increase your risk of early pregnancy loss. Your doctor may give you a pregnancy test before you start using this medicine to ...

7. academic.oup.com academic.oup.com/humrep/article/39/3/526/7577817

Two-year efficacy and safety of relugolix combination therapy ... After discontinuation of treatment, the median time for menstruation resumption was 33 days. Over 90% of patients resumed menses within 2 months ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0015028225002511

Efficacy and safety of relugolix combination therapy in ... The safety findings in the subgroup of women with adenomyosis were comparable with the overall LIBERTY 1/2 population, with a low rate of SAEs and a similar ...