LevoCept for Birth Control

Recruiting at 29 trial locations

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

1525 Participants Needed

Trial Summary

What is the purpose of this trial?

To assess the contraceptive efficacy (prevention of pregnancy) of LevoCept

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.

What data supports the effectiveness of the drug LevoCept for birth control?

LevoCept likely contains levonorgestrel, a hormone used in various contraceptive methods, which has been shown to be effective in preventing pregnancy. Levonorgestrel is used in emergency contraception and intrauterine systems, both of which are highly effective in reducing unintended pregnancies. ^{1 2 3 4 5}

Is LevoCept safe for use as birth control?

LevoCept, which contains levonorgestrel, is generally considered safe for use as a long-term birth control method. However, users may experience side effects like menstrual disturbances, and some may discontinue use due to these effects. Proper counseling can help manage expectations and improve satisfaction. ^{1 6 7 8 9}

How is the drug LevoCept unique for birth control?

LevoCept is unique because it is a levonorgestrel-releasing intrauterine system, which provides long-term contraception by releasing the hormone directly into the uterus, potentially offering a more consistent hormone delivery compared to oral contraceptives or implants. This method may improve compliance and reduce the need for daily or frequent administration. ^{1 10 11 12 13}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

New hormonal contraceptives: a comprehensive review of the literature. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Future developments in hormonal contraception. [2005]

3. United States pubmed.ncbi.nlm.nih.gov

Hormonal emergency contraception. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Acceptance of altering the standard 21-day/7-day oral contraceptive regimen to delay menses and reduce hormone withdrawal symptoms. [2019]

5. United States 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. [2018]

6. New Zealand pubmed.ncbi.nlm.nih.gov

A Systematic Review and Meta-analysis of the Adverse Effects of Levonorgestrel Emergency Oral Contraceptive. [2020]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Review of the safety, efficacy and patient acceptability of the levonorgestrel-releasing intrauterine system. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Levonorgestrel-releasing intrauterine system--the discontinuing story. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The levonorgestrel-releasing intrauterine system: an updated review of the contraceptive and noncontraceptive uses. [2018]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Levonorgestrel subdermal implants. A review of contraceptive efficacy and acceptability. [2018]

11. Brazil pubmed.ncbi.nlm.nih.gov

[Reproductive performance of female wistar rat, descendent of mothers treated with levonorgestrel during the lactation]. [2019]

12. France pubmed.ncbi.nlm.nih.gov

[New forms of hormonal contraception]. [2014]

13. United States pubmed.ncbi.nlm.nih.gov

Pericoital oral contraception with levonorgestrel: a systematic review. [2021]