Progestin Patch for Birth Control

Recruiting at 25 trial locations

Overseen By Sandeep Jagtap Director, Global Clinical Strategy

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Mylan Pharmaceuticals Inc

Must not be taking: Hormonal contraceptives, CYP3A4 inducers

Disqualifiers: Pregnancy, Infertility, Liver issues, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The Sponsor is developing a progestin-only contraceptive transdermal system (patch). The main purpose of this study is to look at how safe the study patch is and how well it works in preventing pregnancy. The study will also look at how well the study patch is tolerated. The study patch is a transdermal system that contains the active ingredient, progestin.

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.

What data supports the effectiveness of the Progestin Only Patch as a birth control treatment?

Research shows that progestin contraceptives, including patches, are effective for birth control. The transdermal patch method, which delivers hormones through the skin, has been shown to have similar effectiveness to oral contraceptives, with better compliance, especially in younger women. ^{1 2 3 4 5}

How does the Progestin Only Patch for birth control differ from other birth control methods?

The Progestin Only Patch is unique because it delivers hormones through the skin, offering a non-invasive and convenient alternative to oral pills or injections. This patch provides a steady release of progestin, which can be beneficial for those who prefer not to take daily pills or receive regular injections. ^{6 7 8 9 10}

Eligibility Criteria

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.

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

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

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

Trial Timeline

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

Treatment Details

Interventions

• Progestin Only Patch (Progestin)

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.

Participant Groups

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

Findings from Research

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]

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 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]

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 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]

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]

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]

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]

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]

References

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

Progestin contraceptives. [2021]

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

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

3. Thailand pubmed.ncbi.nlm.nih.gov

A clinical study of transdermal contraceptive patch in Thai women. [2019]

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

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

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

Low-dose levonorgestrel and ethinyl estradiol patch and pill: a randomized controlled trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Six-year follow-up outcomes of the P(LLA-CL)/Fg bio-patch for anterior vaginal wall prolapse treatment. [2023]

7. Netherlands 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. [2021]

8. Australia pubmed.ncbi.nlm.nih.gov

Treatment of total pelvic organ prolapse using a whole biological patch: A pilot study of 17 patients. [2017]

9. France pubmed.ncbi.nlm.nih.gov

[Laparoscopic sacral colpopexy: comparison of nonresorbable prosthetic tape (Mersuture) and a SIS collagen matrix (Surgisis ES)]. [2018]

10. Italy pubmed.ncbi.nlm.nih.gov

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