MR-100A-01 for Birth Control

No longer recruiting at 156 trial locations

Overseen By Ivette Lopez, Jonathan Balseiro

Age: Any Age

Sex: Female

Trial Phase: Phase 3

Sponsor: Mylan Technologies Inc.

Must not be taking: Estrogens, Progestins

Disqualifiers: Pregnancy, Hypertension, Diabetes, HIV, 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 trial tests a new birth control method called MR-100A-01, a skin patch that delivers hormones to prevent pregnancy. Researchers aim to evaluate its effectiveness, impact on menstrual cycles, and safety over 13 months. Women with regular menstrual cycles who engage in regular heterosexual intercourse and wish to avoid pregnancy for at least a year may be suitable candidates. Participants must agree not to use any other form of contraceptive during the study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of a potential new contraceptive option.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does mention that you cannot be on medications that are prohibited during the study. It's best to discuss your specific medications with the study team to see if they are allowed.

Is there any evidence suggesting that MR-100A-01 is likely to be safe for humans?

Research has shown that the hormones in MR-100A-01, norelgestromin and ethinyl estradiol, have been used in other birth control patches. Studies have found these hormones generally safe and effective for preventing pregnancy.

However, some important safety notes exist. People over 35 who smoke should avoid this type of patch, as smoking can increase the risk of serious side effects like blood clots. Most users find the patch easy to use, making it a good option for those seeking a simple, reversible birth control method. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard birth control options, which often include oral pills, injections, or implants, MR-100A-01 is unique due to its transdermal delivery system. This patch delivers a daily dose of Norelgestromin and Ethinyl Estradiol directly through the skin, which can improve user convenience and adherence. Researchers are excited because this method may offer a more consistent hormone release, potentially reducing side effects and enhancing effectiveness compared to traditional methods.

What evidence suggests that MR-100A-01 might be an effective treatment for birth control?

Research has shown that the MR-100A-01 patch, used by participants in this trial, effectively prevents pregnancy. It contains two hormones, norelgestromin and ethinyl estradiol, which work together to prevent pregnancy. The patch has a low failure rate, making it reliable for most women, particularly those with a body mass index (BMI) under 30. It releases hormones steadily through the skin, maintaining consistent levels in the body. Although effective at preventing pregnancy, it does not protect against sexually transmitted diseases. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

Healthy women who are at least 16 years old, have regular menstrual cycles, and want to avoid pregnancy for at least a year. They must be willing to risk pregnancy, not use other contraceptives or methods to prevent it during the study, and live within 150 miles of the research site. Women under 18 can join if local laws allow them to consent to sexual intercourse and clinical trials.

Inclusion Criteria

You are willing to become pregnant and accept the possible risks associated with it.

Planning to reside within a reasonable driving/ public transport distance of the research site (approximately 150 miles) for around 12 months (13 cycles).

Has demonstrated ability to complete e-Diary.

Exclusion Criteria

You plan to use condoms or other backup contraception methods to prevent sexually transmitted infections or for emergency contraception during the study.

You have had a bad reaction to bandages or surgical tape applied to your skin in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MR-100A-01 transdermal delivery system for contraceptive efficacy over 13 cycles

12 months

Monthly 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

• MR-100A-01

Trial Overview The trial is testing MR-100A-01's ability as a birth control method over up to 13 menstrual cycles in about 1200 women. It will assess how effective it is at preventing pregnancy, its impact on menstrual cycle regularity, safety profile, and overall tolerability.

How Is the Trial Designed?

Group I: MR-100A-01 Experimental Treatment 1 Intervention

MR-100A-01 is a transdermal delivery system designed to deliver daily hormone exposure of Norelgestromin and Ethinyl Estradiol

Who Is Running the Clinical Trial?

Mylan Technologies Inc.

Lead Sponsor

Trials

1

Recruited

1,300+

Mylan Inc.

Industry Sponsor

Trials

63

Recruited

20,800+

Founded

1961

Headquarters

Canonsburg, Pennsylvania, USA

Known For

Generic Medicines

Top Products

EpiPen, Adcirca (Generic Tadalafil), Generic Tecfidera (Dimethyl Fumarate)

Heather Bresch

Mylan Inc.

Chief Executive Officer since 2012

BA in International Studies and Political Science from West Virginia University

Rajiv Malik

Mylan Inc.

Chief Medical Officer since 2013

Master's in Pharmaceutical Technology from Punjab University

Published Research Related to This Trial

The introduction of the Risk Management Plan (RMP) system in Japan in 2013 has improved the monitoring and reporting of unexpected adverse reactions for medical products, enhancing postmarketing safety measures.

Chugai Pharmaceutical is pioneering a patient-focused approach to drug safety by developing tools like the 'PMS & SAFETY DB Tools,' which provide healthcare providers with quick access to real-world safety data, aiming to improve safety assurance and response to adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Making Patient-focused Information Provision a Reality: One Company's Approach]. Takemoto, S.[2018]

Citations

1. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2012/021180s043lbl.pdf

ORTHO EVRA® (norelgestromin / ethinyl estradiol ... The study concluded that with the exception of combination oral contraceptive users 35 and older who smoke, and 40 and older who do not smoke, mortality ...

2. mayoclinic.org mayoclinic.org/drugs-supplements/ethinyl-estradiol-and-norelgestromin-transdermal-route/description/drg-20062923

Ethinyl estradiol and norelgestromin (transdermal route) Norelgestromin and ethinyl Estradiol combination does not prevent AIDS or other sexually transmitted diseases. It will not prevent hepatitis B.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00554632

NCT00554632 | Birth Control Pill vs Birth Control Patch Study The maximum ethinyl estradiol and norelgestromin levels (Cmax) were 133 pg/ml and 2.16 ng/ml for the oral form and 97.4 pg/ml and 1.12 ng/ml for the transdermal ...

4. drugs.com drugs.com/pro/norelgestromin-and-ethinyl-estradiol.html

Norelgestromin and Ethinyl Estradiol: Package Insert / ... Norelgestromin and ethinyl estradiol transdermal system is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 ...

5. 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) ...

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

ORTHO EVRA (NORELGESTROMIN / ETHINYL ESTRADIOL ... The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is ...

7. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10fa1458-c8ed-4197-922a-1ba7271d2b02

Label: NORELGESTROMIN AND ETHINYL ESTRADIOL patch Do not use norelgestromin and ethinyl estradiol transdermal system if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious ...

8. webmd.com webmd.com/drugs/2/drug-180988/zafemy-transdermal/details

Norelgestromin/Ethinyl Estradiol transdermal - Uses, Side ... Find patient medical information for Norelgestromin/Ethinyl Estradiol transdermal on WebMD including its uses, side effects and safety, ...