Progestin Patch for Birth Control

Recruiting at 52 trial locations

Overseen By Sandeep Jagtap Director, Global Clinical Strategy

Age: Any Age

Sex: Female

Trial Phase: Phase 3

Sponsor: Mylan Pharmaceuticals Inc

Must not be taking: Hormonal contraceptives, CYP3A4 inducers

Disqualifiers: Pregnancy, Infertility, Liver issues, 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: 52 weeks

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new birth control patch containing progestin. The main goal is to assess the patch's safety and effectiveness in preventing pregnancy and its tolerability among users. All participants will use this patch, with no other groups testing different treatments. The trial seeks healthy women with regular menstrual cycles who wish to avoid pregnancy for at least a year without using other contraceptives. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the availability of a new contraceptive option.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use other contraceptives during the study. If you are on long-term treatment with drugs or herbal products that affect liver enzymes (CYP3A4), you may not be eligible.

Is there any evidence suggesting that the progestin-only patch is likely to be safe for humans?

Research has shown that progestin, the main ingredient in the study patch, is usually well-tolerated in birth control. Other studies have found similar patches with progestin to be safe, meaning most people did not experience serious side effects. Common side effects include skin reactions at the patch site, headaches, or nausea, but these are typically mild and resolve on their own. This trial is in an advanced stage, indicating that earlier research has demonstrated the treatment to be reasonably safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The Progestin Only Patch is unique because it offers a new delivery method for birth control through a transdermal system, allowing the hormone progestin to be absorbed through the skin. Unlike oral contraceptives that require daily intake, this patch could potentially provide a more convenient option with less frequent dosing. Researchers are excited about this treatment because it could improve user compliance and provide an effective, non-invasive alternative to current birth control methods like pills, injections, and implants.

What evidence suggests that the progestin-only patch is effective for birth control?

Studies have shown that progestin-only contraceptives effectively prevent pregnancy. Participants in this trial will receive the progestin-only patch, which has a pregnancy chance of less than 1% with perfect use and about 4% with typical use, including errors like forgetting to change the patch on time. This means that out of 100 women using the patch for a year, fewer than 4 might become pregnant with typical use. Research also indicates that many people prefer the patch over other methods due to its convenience. Overall, the progestin patch is a reliable birth control method when used correctly. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for women who can have children and are interested in a new birth control method. Participants should be healthy, sexually active, and not currently pregnant or breastfeeding. They must not use other hormonal contraceptives or have conditions that the patch might worsen.

Inclusion Criteria

I plan to use hormonal birth control for at least one year to avoid pregnancy.

Able to understand and voluntarily provide written informed consent or assent (if the participant is adolescent prior to undergoing any trial related procedure) to participate in the study

I am a healthy woman, aged 16 or older, able to have children, and not yet in menopause.

Exclusion Criteria

Has non-hormonal or hormonal intrauterine device (IUD) in place; or has had a recent IUD removal without one spontaneous menses after removal prior to the date of enrollment

Participants with known hypersensitivity or intolerance to progestins, or any components of the progestin patch

History or presence of dermal sensitivity to medicated patches or to topical applications including bandages, surgical tape

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the progestin-only contraceptive patch for 13 cycles

52 weeks

Regular visits for patch application and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Progestin Only Patch

Trial Overview The study is testing a progestin-only contraceptive patch applied to the skin. It aims to evaluate how effective this patch is at preventing pregnancy and assess its safety and tolerability over time.

How Is the Trial Designed?

Group I: This is a single-arm study. Experimental Treatment 1 Intervention

The study patch is a transdermal system that contains the active ingredient progestin. This study is an open-label, single-arm study. This means that all participants in the study will receive the study patch

Who Is Running the Clinical Trial?

Mylan Pharmaceuticals Inc

Lead Sponsor

Trials

166

Recruited

13,000+

Dr. Patrizia Cavazzoni

Mylan Pharmaceuticals Inc

Chief Medical Officer

MD from Harvard Medical School

Heather Bresch

Mylan Pharmaceuticals Inc

Chief Executive Officer since 2012

BA from West Virginia University

Published Research Related to This Trial

In a study involving 41 patients, laparoscopic ventral rectopexy using a self-adhesive prosthesis showed no major complications or recurrence of rectal prolapse after a median follow-up of 30 months.

The self-adhesive prosthesis, made from polypropylene and coated with synthetic hydrogel, allows for fixation without stitches or staples, demonstrating a safe and effective method for treating complete rectal prolapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Wrap technique": a new operative procedure using a self-adhesive prosthesis for laparoscopic ventral rectopexy. Gravié, JF., Maigné, C.[2018]

New progestins in combination contraceptives can effectively prevent pregnancy while reducing androgenic side effects and alleviating symptoms of premenstrual dysphoric disorder.

Innovative delivery systems and regimens for these contraceptives have been developed to enhance user comfort and adherence, making it easier for patients to consistently use birth control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The state of hormonal contraception today: benefits and risks of hormonal contraceptives: combined estrogen and progestin contraceptives. Shulman, LP.[2011]

The new low-dose levonorgestrel and ethinyl estradiol contraceptive Patch demonstrated efficacy and safety comparable to the traditional oral contraceptive Pill in a study involving 1,504 women, with similar rates of unscheduled bleeding and adverse events.

Compliance rates were also similar between the Patch and Pill, with laboratory-verified noncompliance at 11% for Patch users and 12.6% for Pill users, indicating that both methods are well tolerated and effective for contraception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose levonorgestrel and ethinyl estradiol patch and pill: a randomized controlled trial. Kaunitz, AM., Portman, D., Westhoff, CL., et al.[2021]

In a 6-year follow-up study of 19 patients with anterior pelvic organ prolapse, the use of a bio-compatible P(LLA-CL)/Fg patch resulted in a high anatomical cure rate of 93.8%, indicating its long-term efficacy in treating this condition.

The bio-patch was well-tolerated with minimal complications, showing only one case of infection and one case of urinary retention, while demonstrating complete absorption within 3 months, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-year follow-up outcomes of the P(LLA-CL)/Fg bio-patch for anterior vaginal wall prolapse treatment. Wu, C., Zhang, Z., He, H., et al.[2023]

In a study of 57 patients undergoing laparoscopic sacral colpopexy, the use of Small Intestinal Submucosa (SIS) tape resulted in only one case of recurrent prolapse, suggesting its effectiveness as a surgical option.

SIS tape showed no infectious complications and may have a lower long-term risk of infection and erosion compared to traditional nonresorbable PETP tape, as it is replaced by new connective tissue within 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Laparoscopic sacral colpopexy: comparison of nonresorbable prosthetic tape (Mersuture) and a SIS collagen matrix (Surgisis ES)]. Grynberg, M., Dedecker, F., Staerman, F.[2018]

Progestin contraceptives provide customizable options for women, enabling healthcare providers to create tailored regimens that meet individual needs.

The review discusses the different types of progestational drugs and delivery systems, highlighting their clinical benefits and limitations, which can help inform better contraceptive choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progestin contraceptives. Schnare, SM.[2021]

The transdermal contraceptive patch was well-received by 69 Thai women, showing good compliance and minimal side effects, with only 1.1% experiencing breakthrough bleeding.

Participants reported benefits such as reduced dysmenorrhea, shorter bleeding duration, and improved facial acne, while no pregnancies occurred during the study, indicating its efficacy as a contraceptive method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical study of transdermal contraceptive patch in Thai women. Suwanmalee, O., Taneepanichskul, S.[2019]

In a study of 17 patients with severe pelvic organ prolapse, the use of a complete and non-splice porcine small-intestine submucosa (SIS) patch for total pelvic anatomical repair showed a high success rate, with 92.85% of patients maintaining stable anatomical positions after surgery.

The procedure was safe, with no reported cases of organ damage, infection, or rejection, and no symptom recurrence in patients with combined stress urinary incontinence, indicating its efficacy and safety for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of total pelvic organ prolapse using a whole biological patch: A pilot study of 17 patients. Liang, X., Zhang, L., Lv, Y.[2017]

The transdermal contraceptive patch (ethinylestradiol/norelgestromin) offers similar efficacy to oral contraceptives but improves user adherence with its once-weekly administration, reducing the likelihood of pregnancy.

The patch has a favorable safety profile and is more cost-effective than oral contraceptives, particularly due to lower costs associated with unintended pregnancies, making it a suitable option for women, including those with androgen-related disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of transdermal hormonal contraception : focus on the ethinylestradiol/norelgestromin contraceptive patch. Graziottin, A.[2019]

The study developed a novel aloe/poloxamer hydrogel for delivering β-estradiol (E2) to promote endometrial regeneration in rats with intrauterine adhesions (IUA), showing significant improvements in tissue recovery and reduced fibrosis compared to other treatment groups.

The E2@uECMNPs/AP hydrogel not only enhanced cell proliferation and reduced apoptosis in endometrial stromal cells but also modulated key molecular markers, indicating its potential as an effective therapy to prevent re-adhesion after IUA treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aloe/poloxamer hydrogel as an injectable β-estradiol delivery scaffold with multi-therapeutic effects to promote endometrial regeneration for intrauterine adhesion treatment. Yao, Q., Zheng, YW., Lan, QH., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2770395/

Safety, efficacy and patient acceptability of the combined ... The transdermal contraceptive patch was shown to be a reliable method of contraception, with a Pearl Index (the number of pregnancies per 100 women-years of use) ...

2. mayoclinic.org mayoclinic.org/tests-procedures/birth-control-patch/about/pac-20384553

Birth control patch Pregnancy rates are estimated to be 7 to 9 out of 100 women during a year of typical use. Typical use situations might include forgetting to ...

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2787541

Contraception Selection, Effectiveness, and Adverse Effects Typical effectiveness of DMPA and progestin-only contraceptive pills is 4 to 7 pregnancies per 100 women in a year.

4. gremjournal.com gremjournal.com/journal/02-03-2023/statement-on-transdermal-contraception-as-an-underused-option-for-unmet-needs-in-contraception-the-importance-of-structured-counselling/

Statement on transdermal contraception as an underused ... At the end of the study 74% preferred the patch over their previous method. Nearly 90.5% of cycles were completed with perfect compliance. The ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7533104/

An Evidence-Based Update on Contraception The failure rate is less than 1% with perfect use and 4% with typical use. In addition to the aforementioned progestin mechanisms of action, DMPA also affects ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2005/021180s015lbl.pdf

ORTHO EVRA (NORELGESTROMIN / ETHINYL ESTRADIOL ... is a combination transdermal contraceptive patch with a contact surface area of 20 cm2. It contains 6.00 mg norelgestromin and 0.75 mg ethinyl.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00236769

A Study of Efficacy and Safety With the Transdermal ... The purpose of the study is to evaluate the contraceptive efficacy, safety, cycle control, and compliance with the transdermal contraceptive system.

8. ajog.org ajog.org/article/S0002-9378(07)00548-0/fulltext

Transdermal hormonal contraception: benefits and risks Clinical data demonstrated the efficacy and safety of the contraceptive patch; however, concerns regarding estrogen levels and reports of venous thromboembolism ...