LevoCept for Birth Control

Not yet recruiting at 29 trial locations

Overseen By Rovena Reagan, MD

Age: < 65

Sex: Female

Trial Phase: Phase 3

Sponsor: Sebela Women's Health Inc.

Must not be taking: Estrogen, Progesterone, Testosterone, others

Disqualifiers: Pregnancy, Cancer, Liver disease, 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: 1

Duration: 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new intrauterine contraceptive called LevoCept to evaluate its effectiveness in preventing pregnancy. It targets women seeking a reliable birth control method who are in a steady, monogamous relationship. Participants should have regular menstrual cycles, be sexually active with a male partner, and wish to avoid pregnancy during the study. This trial offers a chance to try a new form of contraception and helps researchers gather data on its effectiveness. As a Phase 3 trial, it represents the final step before FDA approval, allowing participants to contribute to the development of a potentially groundbreaking contraceptive method.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot use any non-contraceptive estrogen, progesterone, or testosterone during the study.

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

Research shows that LevoCept is generally safe for long-term birth control. LevoCept contains levonorgestrel, a hormone commonly used in birth control methods. Studies have found that this type of long-acting reversible contraception (LARC) is well-tolerated.

Earlier research tested LevoCept for both efficacy and safety. The positive results encouraged further studies, indicating good safety. The American College of Obstetricians and Gynecologists recommends intrauterine devices like LevoCept as safe birth control options.

While detailed safety results from these studies aren't provided here, LevoCept's progression to later testing stages suggests no major safety concerns have arisen so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

LevoCept is unique because it is an innovative intrauterine contraceptive device designed to offer long-term birth control with potentially fewer side effects compared to current options like hormonal IUDs and copper IUDs. Researchers are excited about LevoCept because it utilizes a new delivery system that may provide effective contraception for several years while minimizing hormonal exposure, which can reduce the risk of side effects commonly associated with other hormonal methods. Additionally, LevoCept's design could offer a more comfortable insertion and removal experience, making it an appealing choice for those seeking reliable, low-maintenance birth control.

What evidence suggests that LevoCept is effective for birth control?

Research has shown that LevoCept, the investigational treatment in this trial, effectively prevents pregnancy. LevoCept likely uses levonorgestrel, a hormone effective in many birth control methods. Studies indicate that IUDs releasing levonorgestrel are very effective and have a lower chance of pregnancy compared to copper IUDs. One study confirmed that a similar levonorgestrel system remained highly effective for up to 8 years. This evidence supports LevoCept's potential effectiveness for birth control. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for pre-menopausal women up to age 45 who are in good health, have regular menstrual cycles, and are sexually active with a male partner. They must not be pregnant or at risk of pregnancy from recent unprotected intercourse, have no history of IUD complications, and agree to use LevoCept as their only birth control method. Women with certain uterine anomalies or severe cervical stenosis, untreated acute cervicitis or vaginitis, liver disease, HIV/AIDS, drug abuse within the last year, high risk for STIs or known allergies to LevoCept components cannot participate.

Inclusion Criteria

You are okay with the possibility of getting pregnant during the trial.

I am a woman under 45, have started menstruating, and am in good health.

Seeking to avoid pregnancy for the duration of the study

Exclusion Criteria

A previously inserted IUD/IUS that has not been removed by the time the study IUS is placed

I have a liver disease or tumor.

You have a weakened immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the LevoCept intrauterine contraceptive

3 years

Day 1 for placement, annual visits for continuation assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Annual visits for continuation assessment

What Are the Treatments Tested in This Trial?

Interventions

• LevoCept

Trial Overview The study is testing the effectiveness of LevoCept as a contraceptive device. It aims to prevent pregnancy in participating women who will use this intrauterine system (IUS) as their sole form of birth control throughout the study period.

How Is the Trial Designed?

Group I: LevoCept Experimental Treatment 1 Intervention

LevoCept™ Intrauterine Contraceptive

Who Is Running the Clinical Trial?

Sebela Women's Health Inc.

Lead Sponsor

Trials

6

Recruited

4,100+

Sebela Pharmaceuticals Inc.

Lead Sponsor

Trials

6

Recruited

4,100+

PRA Health Sciences

Industry Sponsor

Trials

95

Recruited

42,500+

Colin Shannon

PRA Health Sciences

Chief Executive Officer since 2010

BSc in Economics and MBA from the Wharton School, University of Pennsylvania

Dr. Kirsten Gruis

PRA Health Sciences

Chief Medical Officer since 2023

MD from McGill University

Published Research Related to This Trial

In a pilot study involving 14 women (9 with normal BMI and 5 obese), a new long-acting injectable contraceptive formulation of levonorgestrel butanoate (LB) showed that most participants returned to ovulation before the expected 6-month period, indicating its potential efficacy as a contraceptive.

Interestingly, the obese group returned to ovulation earlier than the normal BMI group, with 60% of obese participants ovulating within 90 days compared to none in the normal BMI group, suggesting that the formulation may have different effects based on body mass index.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Levonorgestrel butanoate intramuscular injection does not reliably suppress ovulation for 90 days in obese and normal-BMI women: a pilot study. Edelman, AB., Cherala, G., Li, H., et al.[2018]

New hormonal contraceptive methods, such as the norelgestromin-ethinyl estradiol patch and etonogestrel-ethinyl estradiol vaginal ring, aim to improve compliance and reduce side effects compared to traditional oral contraceptives, which are taken daily.

Despite their different administration methods, these new contraceptives maintain similar efficacy and adverse effect profiles to oral contraceptives, making them viable alternatives for women who may struggle with daily pill adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New hormonal contraceptives: a comprehensive review of the literature. Forinash, AB., Evans, SL.[2019]

The introduction of new contraceptive methods, including long-term options like the transdermal patch and vaginal ring, offers women more effective and convenient choices for preventing pregnancy, with safety profiles comparable to traditional oral contraceptives.

With 60% of unintended pregnancies occurring among women using birth control, the expanded range of contraceptive options is expected to improve user compliance and effectiveness, tailoring solutions to individual needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Future developments in hormonal contraception. Johansson, ED.[2005]

Three new hormonal contraceptives have been identified that offer high effectiveness with lower dosages, improving safety and tolerance: a low-dose combination of ethinylestradiol and gestodene, a progestogen-only subcutaneous implant with etonogestrel, and a levonorgestrel-releasing intrauterine system.

These contraceptive options allow for better personalization of therapy, catering to individual needs and preferences in contraception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New forms of hormonal contraception]. Gaspard, U., Buicu, C., van den Brûle, F.[2014]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02882191

Evaluation of the Efficacy and Safety of LevoCept To evaluate the effectiveness, device placement, safety, and tolerability of LevoCept to support commencing a Phase III Clinical Study. Detailed Description.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39610901/

Contraception with levonorgestrel-releasing intrauterine ... LNG-IUDs and Cu-IUDs are both highly effective contraceptive methods. Compared to Cu-IUDs, LNG-IUDs were associated with a lower risk of pregnancy and adverse ...

3. withpower.com withpower.com/trial/phase-3-6-2022-a09d7

LevoCept for Birth Control · Info for Participants LevoCept likely contains levonorgestrel, a hormone used in various contraceptive methods, which has been shown to be effective in preventing pregnancy.

4. ajog.org ajog.org/article/S0002-9378(22)00366-0/fulltext

Levonorgestrel 52 mg intrauterine system efficacy and ... The levonorgestrel 52 mg intrauterine system is highly effective over 8 years of use and has an excellent extended safety profile. This report ...

5. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00505-4/fulltext

a meta-analysis of randomized controlled trials This study aims to comprehensively evaluate the potential differences between intrauterine devices using available multinational data

6. sebelapharma.com sebelapharma.com/long-acting-reversible-contraception

Long-Acting Reversible Contraception (LARC) The American College of Obstetricians and Gynecologists recommends Long-Acting Reversible Contraception (LARC), such as intrauterine devices (IUDs), as a safe ...

7. ctv.veeva.com ctv.veeva.com/study/evaluation-of-the-efficacy-safety-and-tolerability-of-levocept

Evaluation of the Efficacy, Safety, and Tolerability of LevoCept Subjects who are 25 or older at the time of informed consent must have a normal Pap test or an ASC-US result with a negative high-risk human ...

8. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT02882191?keyword=%22Contraception%22

Evaluation of the Efficacy and Safety of LevoCept Study Design:~Prospective, multi-center, single-arm, open-label, Phase II clinical study~Approximately 250 subjects will be enrolled at about 14 centers in ...