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Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

1319 Participants Needed

MR-100A-01 for Birth Control

Recruiting at 151 trial locations

Overseen ByIvette 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 GroupAll 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 DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial is studying a birth control patch called MR-100A-01 in women. The patch contains hormones that prevent pregnancy by stopping ovulation and making it harder for sperm to reach eggs. The study will look at how well the patch works, how it affects menstrual cycles, and its safety and tolerability. The MR-100A-01 patch is similar to other transdermal contraceptive patches that have been studied for their effectiveness in preventing ovulation and controlling menstrual cycles.

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.

What data supports the effectiveness of the drug MR-100A-01 for birth control?

The research on Lunelle, a monthly contraceptive injection containing medroxyprogesterone acetate and estradiol cypionate, shows that it is well accepted by women, with over 90% of users having a favorable experience and recommending it to friends. This suggests that similar components in MR-100A-01 could also be effective for birth control.¹ ² ³ ⁴ ⁵

What safety data exists for MR-100A-01 or similar treatments?

The safety data for methyldopa, a treatment evaluated for other conditions, shows that common adverse reactions include fever, hemolysis (breakdown of red blood cells), and liver effects. Most patients experiencing these reactions were hospitalized, and two-thirds were women.⁶ ⁷ ⁸ ⁹ ¹⁰

How does the drug MR-100A-01 for birth control differ from other treatments?

The drug MR-100A-01 is unique because it is a low-dose oral contraceptive containing 100 micrograms of levonorgestrel and 20 micrograms of ethinyl estradiol, offering similar contraceptive efficacy to higher-dose options while maintaining a consistent safety profile.¹¹ ¹² ¹³ ¹⁴ ¹⁵

Eligibility Criteria

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.

See 8 more

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

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

Treatment Details

Interventions

MR-100A-01

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: MR-100A-01Experimental Treatment1 Intervention

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mylan Technologies Inc.

Lead Sponsor

Trials

Recruited

1,300+

Mylan Inc.

Industry Sponsor

Trials

Recruited

20,800+

Founded

1961

Headquarters

Canonsburg, Pennsylvania, USA

Known For

Generic Medicines

Findings from Research

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]

References

1.United Statespubmed.ncbi.nlm.nih.gov

Patient acceptability and satisfaction with Lunelle monthly contraceptive injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension). [2019]

2.Englandpubmed.ncbi.nlm.nih.gov

Long-term safety and tolerability of continuous-combined hormone therapy in postmenopausal women: results from a seven-year randomised comparison of low and standard doses. [2019]

3.Englandpubmed.ncbi.nlm.nih.gov

Weight, fat mass, and central distribution of fat increase when women use depot-medroxyprogesterone acetate for contraception. [2022]

4.United Statespubmed.ncbi.nlm.nih.gov

Evaluation of efficacy, safety and effects on symptoms of androgenization of a generic oral contraceptive containing chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg. [2013]

5.Englandpubmed.ncbi.nlm.nih.gov

Relapse risk of endometrial hyperplasia after treatment with the levonorgestrel-impregnated intrauterine system or oral progestogens. [2021]

6.Swedenpubmed.ncbi.nlm.nih.gov

Adverse reactions with methyldopa--a decade's reports. [2019]

7.Japanpubmed.ncbi.nlm.nih.gov

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

8.Switzerlandpubmed.ncbi.nlm.nih.gov

Risk Management Plans in the European Union: Nonclinical Aspects. [2020]

9.Nepalpubmed.ncbi.nlm.nih.gov

Adverse Drug Reaction (ADR) Monitoring at the Eastern Regional Pharmacovigilance Centre, Nepal. [2019]

10.United Statespubmed.ncbi.nlm.nih.gov

Regulatory assessment of reproductive toxicology data. [2012]

11.United Statespubmed.ncbi.nlm.nih.gov

A new low-dose monophasic combination oral contraceptive (Alesse) with levonorgestrel 100 micrograms and ethinyl estradiol 20 micrograms. North American Levonorgestrel Study Group (NALSG). [2019]

12.United Statespubmed.ncbi.nlm.nih.gov

Male hormonal contraception. [2013]

13.Germanypubmed.ncbi.nlm.nih.gov

Effects of levonorgestrel butanoate alone and in combination with testosterone buciclate on spermatogenesis in the bonnet monkey. [2018]

14.Netherlandspubmed.ncbi.nlm.nih.gov

Male contraception. [2018]

15.Englandpubmed.ncbi.nlm.nih.gov

Advances in male contraception. [2019]