Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles

Contraception Clinical Trial

Official title:

A Phase 3, Multicenter, Open-Label, Single Arm Study of MR-100A-01 in Women of Childbearing Potential to Evaluate Contraceptive Efficacy and Safety

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05139121
• Other study ID #: MR-100A-01-TD-3001
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 26, 2021
• Est. completion date: January 2025

Study information

• Verified date: June 2024
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study of the contraceptive efficacy, cycle control, safety, and tolerability of MR-100A-01 in approxmiately 1200 women for up to 13 cycles

Description:

MR-100A-01 is a TDS of norelgestromin 4.86 mg/ethinyl estradiol 0.264 mg. This study will evaluate the contraceptive efficacy, cycle control, safety, and tolerability of MR-100A-01.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1321
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

1. Healthy, post-menarcheal and premenopausal women at risk of pregnancy who are at least 16 years of age with no upper age limit. Post-menarcheal female subjects who are at risk of pregnancy, and <18 years are eligible provided that:

1. Applicable national, state, and local laws allow the subject to consent to sexual intercourse,

2. Applicable national, state, and local laws allow subjects in this age group to consent/assent to receive contraceptive services, and

3. All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed.

2. Desires to avoid pregnancy, is seeking to use hormonal contraception for at least 1 year.

3. Has negative UPT results at screening and at enrollment visits.

4. Has normal, regular menstrual cycles that are between 21 and 35 days.

5. Engages in regular heterosexual vaginal intercourse.

6. Agrees not to use other contraceptives or other methodology to prevent pregnancy during the study.

7. Able to understand and voluntarily provide written informed consent or assent to participate in the study.

8. Able to understand and willing to be compliant with study procedures.

9. Willing to accept a risk of pregnancy.

10. Has demonstrated ability to complete e-Diary.

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

Exclusion Criteria:

1. Known or suspected pregnancy or planning pregnancy during next 12 months.

2. Subjects with known hypersensitivity or intolerance to estrogens, progestins, or any components of the MR-100A-01 product.

3. History or presence of dermal sensitivity to topical applications including bandages, surgical tape.

4. Known infertility (current or known history) or history of sterilization in either partner.

5. Received injectable hormonal contraceptive therapy within 10 months of study enrollment or has had less than 2 consecutive, spontaneous menses after an injectable hormonal contraceptive was received at least 10 months earlier.

6. Current use of hormonal contraceptive implants (still implanted; or if an implant was removed, less than 3 consecutive spontaneous menses have occurred between removal and enrollment).

7. 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.

8. Recent surgical or medical abortion, miscarriage, ectopic pregnancy, or vaginal or cesarean delivery and have had less than 3 consecutive, spontaneous menses or withdrawal bleeding episodes prior to enrollment.

9. Subjects lactating at the time of screening into the study.

10. Anticipates routine use of condoms or any other form of back-up contraception for protection from sexually transmitted infections during the study or for emergency contraception.

11. Subjects having a known contraindication to combined hormonal contraception as listed below:

1. Smoker who is =35 years old.

2. History or presence of ischemic heart disease, coronary artery disease, myocardial infarction, stroke, other cerebrovascular diseases including transient ischemic attacks (TIAs), valvular heart disease with complications (pulmonary hypertension, risk for atrial fibrillation, or history of subacute bacterial endocarditis), peripartum cardiomyopathy.

3. History or presence of hypertension (including adequately controlled hypertension) or hypertension with vascular disease or elevated blood pressure (BP) defined as systolic BP =140 mm Hg or diastolic BP =90 mm Hg, measured in sitting position after 5 minutes of rest, considering the average of two readings measured 1 to 2 minutes apart

4. History or presence of deep vein thrombosis/pulmonary embolism (DVT/PE) or superficial venous thrombosis.

5. Has any comorbid condition that may require major surgery with prolonged immobilization during the study period.

6. Subjects with known inherited or acquired hypercoagulopathy.

7. History or presence of systemic lupus erythematosus.

8. History or presence of neurological conditions including migraine with aura at any age, migraine without aura in women =35 years age or in women who smoke, or multiple sclerosis with prolonged immobility.

9. History or presence of or suspected carcinoma of breast.

10. Has diabetes mellitus with nephropathy, retinopathy, neuropathy, or other vascular disease or diabetes of >20 years' duration.

11. Has inflammatory bowel disease (ulcerative colitis or Crohn's disease) who are at increased risk for VTE

12. Medically treated or presence of symptomatic gall bladder disease.

13. History of combined hormonal contraceptive/pregnancy-related cholestasis/jaundice.

14. Presence of liver disease.

15. History of organ transplantation within 5 years before screening or chronic disease potentially necessitating organ transplantation during the anticipated course of the study.

16. Subject has requirement to be on treatment with medications prohibited during study.

12. Known or suspected estrogen or progestin sensitive malignant or premalignant conditions.

13. History of any other condition that in the Investigator's opinion suggests an elevated risk of arterial or venous thromboembolic disease.

14. Has uncontrolled thyroid disorder.

15. Has diagnosis of hereditary angioedema.

16. Has hyperlipidemia on screening.

17. Has uncontrolled diabetes mellitus.

18. Subjects with abnormal significant liver function tests.

19. Has a significantly abnormal cervical cancer screening test (cervical cytology with reflex human-papilloma-virus (HPV) testing or with HPV co-testing) performed at screening visit (for subjects aged =21 years) i.e., cervical dysplasia or invasive cervical cancer or has any abnormal cytology with/without HPV testing during 6 months prior to screening which may require additional screening or treatment during the study period

20. Subjects with chlamydial or gonorrheal infection.

21. Has unexplained vaginal bleeding.

22. History of known or suspected hepatitis B or C infection or high risk for sexually transmitted disease (STD).

23. Known human immunodeficiency virus (HIV) infection or positive confirmatory test at screening.

24. Current known active infection of coronavirus disease 2019 (COVID-19) or increased risk of COVID-19 related morbidity. Subjects who have had previous COVID-19 infections but have recovered by the time of enrollment visit may be enrolled if there are no current COVID-19 symptoms; Subjects who had previously received COVID-19 vaccine may be enrolled irrespective of the timing of the vaccination.

25. Within the past year, either history of suicidal ideation or attempt or severe depression requiring hospitalization.

26. Presence of any other concomitant disease or laboratory result that may worsen under hormonal treatment based on Investigator's discretion.

27. Positive urine drug screen.

28. Recent history (within prior 12 months) of drug or alcohol abuse or at Investigator discretion, history greater than 12 months prior and at risk for noncompliance. Current or recent history of (recreational or medicinal) marijuana use is not exclusionary at the investigator's discretion upon assessment of any potential risk.

29. Participation in an investigational study within 30 days prior to enrollment or intention to participate within next 13 months.

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• MR-100A-01
Transdermal contraceptive delivery system

Locations

Country	Name	City	State
Canada	Centricity Research Quebec City	Levis	Quebec
Canada	Clinique RSF Inc.	Quebec
Canada	Diex Recherche Victoriaville	Victoriaville	Quebec
Puerto Rico	Puerto Rico Medical Research, Inc	Ponce
United States	Bosque Women's Care	Albuquerque	New Mexico
United States	Velocity Clinical Research- Albuquerque	Albuquerque	New Mexico
United States	Agile Clinical Research Trials	Atlanta	Georgia
United States	Medisense Inc.	Atlanta	Georgia
United States	Alliance Research Institute	Bell Gardens	California
United States	Essential Access Health	Berkeley	California
United States	Quantum Clinical Trials	Boynton Beach	Florida
United States	Montefiore Medical Center	Bronx	New York
United States	New York Clinical Trials - Brooklyn	Brooklyn	New York
United States	Velocity Clinical Research-Charleston	Charleston	South Carolina
United States	Javara Inc. Tryon Medical-South Park	Charlotte	North Carolina
United States	Chattanooga Medical Research LLC	Chattanooga	Tennessee
United States	Javara Inc/Privia Medical Group, LLC	Chevy Chase	Maryland
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Velocity Clinical Research, Cleveland	Cleveland	Ohio
United States	Clinical Trials Management	Covington	Louisiana
United States	Velocity Clinical Research - Covington	Covington	Louisiana
United States	DCT-HCWC, LLC dba Discovery Clinical Trials	Dallas	Texas
United States	CenExel iResearch Atlanta, LLC	Decatur	Georgia
United States	Soapstone Center for Clinical Research	Decatur	Georgia
United States	Physicians' Research Options, LLC Corner Canyon Clinic	Draper	Utah
United States	Aventiv Research - Columbus	Dublin	Ohio
United States	Carolina Women's Research And Wellness Center	Durham	North Carolina
United States	Ob/Gyn Associates Of Erie	Erie	Pennsylvania
United States	SBL Special Services	Frederick	Maryland
United States	Aventura OB/GYN Associates	Hallandale Beach	Florida
United States	CenExel RCA	Hollywood	Florida
United States	Global Research Associates	Homestead	Florida
United States	Velocity Clinical Research - Huntington Park	Huntington Park	California
United States	Cedar Health Research	Irving	Texas
United States	UF Health Woman's Specialist - Emerson	Jacksonville	Florida
United States	Alliance for Multispecialty Research, LLC.	Knoxville	Tennessee
United States	Multi-Specialty Research Associates	Lake City	Florida
United States	WR-Multi-Specialty Research Associates LLC	Lake City	Florida
United States	Altus Research	Lake Worth	Florida
United States	Red Rocks Ob-Gyn	Lakewood	Colorado
United States	Excel Clinical Research	Las Vegas	Nevada
United States	Office of Edmond Pack, MD	Las Vegas	Nevada
United States	Wake Research Clinical Research Center of Nevada - Emergency Medicine	Las Vegas	Nevada
United States	Ob-Gyn Associates Of Mid-Florida, PA	Leesburg	Florida
United States	Axis Clinical Trials	Los Angeles	California
United States	Essential Access Health	Los Angeles	California
United States	Matrix Clinical Research	Los Angeles	California
United States	Velocity Clinical Research - Gardena	Los Angeles	California
United States	Velocity Clinical Research, Panorama City	Los Angeles	California
United States	Hassman Research Institute	Marlton	New Jersey
United States	Praetorian Pharmaceutical Research, LLC	Marrero	Louisiana
United States	WR-Medical Research Center of Memphis, LLC.	Memphis	Tennessee
United States	Velocity Clinical Research, Boise	Meridian	Idaho
United States	Mesa Obstetricians and Gynecologists.	Mesa	Arizona
United States	Velocity Clinical Research Metairie	Metairie	Louisiana
United States	AdMed Research, LLC	Miami	Florida
United States	Advanced Pharma CR LLC	Miami	Florida
United States	Avantis Clinical Research	Miami	Florida
United States	New Age Medical Research Corporation	Miami	Florida
United States	ProCare Research Center, Corp.	Miami Gardens	Florida
United States	Global Health Research Center	Miami Lakes	Florida
United States	Planned Parenthood of Minnesota	Minneapolis	Minnesota
United States	Mobile Ob-Gyn, P.C.	Mobile	Alabama
United States	Velocity Clinical Research	Mobile	Alabama
United States	Venus Gynecology, LLC.	Myrtle Beach	South Carolina
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	Columbia University Medical Center	New York	New York
United States	Eastern Virginia Medical School, Clinical Research Center	Norfolk	Virginia
United States	Tidewater Clinical Research/TPW	Norfolk	Virginia
United States	Healthcare Clinical Data, Inc. - Segal Institute for Clinica	North Miami	Florida
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Clintheory Healthcare Miami	Orlando	Florida
United States	Stanford University, School of Medicine, Department of Obstetrics and Gynecology	Palo Alto	California
United States	Advances In Health, Inc.	Pearland	Texas
United States	Clinical Research of Philadelphia	Philadelphia	Pennsylvania
United States	University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	Precision Trials AZ	Phoenix	Arizona
United States	University of Pittsburgh Medical Center (UPMC)	Pittsburgh	Pennsylvania
United States	Physicians' Research Options, LLC	Pleasant Grove	Utah
United States	Empire Clinical Research	Pomona	California
United States	Oregon Health & Science University Center for Women's Health	Portland	Oregon
United States	M3 Wake Research, Inc.	Raleigh	North Carolina
United States	Unified Women's Clinical Research Raleigh	Raleigh	North Carolina
United States	Virginia Women's Health Associates	Reston	Virginia
United States	Northern California Research Corp	Sacramento	California
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Women's Health Care Research Corp.	San Diego	California
United States	Wr-McCr, Llc	San Diego	California
United States	Amicis Research Center	San Fernando	California
United States	WR-Mount Vernon Clinical Research, LLC	Sandy Springs	Georgia
United States	Physician Care Clinical Research	Sarasota	Florida
United States	CenExel iResearch, LLC	Savannah	Georgia
United States	Fellows Research Alliance, Inc.	Savannah	Georgia
United States	Seattle Clinical Research Center	Seattle	Washington
United States	Visions Clinical Research Tucson	Tucson	Arizona
United States	IntimMedicine Specialists	Washington	District of Columbia
United States	Velocity Clinical Research - Salt Lake City	West Jordan	Utah
United States	Comprehensive Clinical Trials, LLC	West Palm Beach	Florida
United States	Upstate Clinical Research Associates	Williamsville	New York
United States	Unified Women's Clinical Research d/b/a Lyndhurst Clinical R	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Mylan Technologies Inc.	Mylan Inc.

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contraceptive efficacy of MR-100A-01 when used over thirteen 28-day cycles in healthy, post-menarcheal, premenopausal, heterosexually active female subjects of childbearing potential who are at least 16 years of age and at risk of pregnancy	The primary efficacy endpoint will be pregnancy rate described by Pearl Index (PI). PI is defined as the number of pregnancies per 100 women-years times 100	12 months (13 cycles)
Secondary	Cycle-wise pregnancy rates over 1 year evaluated using life table analysis [secondary efficacy]	The rate of cycle-wise pregnancies	12 months (13 cycles)
Secondary	Cumulative pregnancy rates over 1 year evaluated using life table analysis [secondary efficacy]	The rate of cycle-wise pregnancies	12 months (13 cycles)
Secondary	Method failure Pearl Index (PI) [secondary efficacy]	The method failure PI is defined as PI among all complete or incomplete on therapy cycles in which intercourse occurred and protocol guidelines were not followed	12 months (13 cycles)
Secondary	Incidence of adverse events (AEs) [safety and tolerability]	The number of AEs	12 months (13 cycles)
Secondary	Incidence of serious adverse events (SAEs) [safety and tolerability]	The number of SAEs	12 months (13 cycles)
Secondary	Incidence of application site reactions [safety and tolerability]	The number of application site reactions	12 months (13 cycles)
Secondary	Number of episodes of scheduled and unscheduled bleeding [cycle control]	The number of incidences of scheduled and unscheduled bleeding	12 months (13 cycles)
Secondary	Number of days of scheduled and unscheduled bleeding [cycle control]	The observed number of days of scheduled or unscheduled bleeding	12 months (13 cycles)
Secondary	Proportion of subjects reporting scheduled and unscheduled bleeding [cycle control]	The number of subjects reporting scheduled and unscheduled bleeding	12 months (13 cycles)
Secondary	Adhesion performance as measured by adhesion scores [patch adhesion]	The descriptive figures of adhesion performance	12 months (13 cycles)