Clinical trial NCT06672016: Study to Evaluate Contraceptive Efficacy and Safety of a Progestin Only Patch in Women of Childbearing Potential
Official title: A Phase 3, Multicenter, Open-Label, Single-Arm Study of MR-130A-01 in Women of Childbearing Potential to Evaluate Contraceptive Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Female Contraception
Keywords: Female, Contraception, Progestin, Transdermal, Patch
Prevent Pregnancy
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Unintended pregnancy continues to be a significant reproductive health problem worldwide. Although the increase in the availability of longer-acting contraceptive methods has improved the situation, the continuing development of newer safe and effective contraception is crucial for women's health.

The development of a progestin-only contraceptive with more convenient dosing may provide women with additional options. The investigational patch is intended to provide an option for women who may not be able to use estrogen-containing combined hormonal contraceptives

Eligibility criteria: Inclusion Criteria:

1. Healthy, post-menarcheal and premenopausal women at risk of pregnancy who are at least 16 years of age.
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 in duration over the last 6 months.
5. Engages in regular heterosexual vaginal intercourse (at least once per cycle), with a partner who is not known to be sub fertile or infertile.
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 (if the participant is adolescent prior to undergoing any trial related procedure) to participate in the study.

Exclusion Criteria:

1. Known or suspected pregnancy or planning pregnancy during next 12 months.
2. Participants with known hypersensitivity or intolerance to progestins, or any components of the progestin patch.
3. History or presence of dermal sensitivity to medicated patches or 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.
6. Current use of hormonal contraceptive implants.
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.
9. Participants lactating at the time of screening into the study or has occurrence of less than 3 regular menstrual cycles after cessation of lactation.
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. Participants having a known contraindication to progestin-only contraception.
12. Known or suspected progestin sensitive malignant or premalignant conditions including but not limited to carcinoma of endometrium, ovary, or fallopian tubes.
13. Skin abnormality (e.g., tattoo or scar) at all possible application sites.
14. Long-term treatment with drugs or herbal products that are moderate/strong inducers or inhibitors of CYP3A4.
15. Has uncontrolled thyroid disorder (thyrotoxicosis or myxedema).
16. Has diagnosis of hereditary angioedema.
17. Participants with abnormal significant liver function tests as measured by liver function tests
18. Has a significantly abnormal cervical cancer screening test.
19. Participants with chlamydial or gonorrheal infection at screening.
20. Has unexplained vaginal bleeding within the past 6 months or any abnormal bleeding which is expected to recur during the study.

Primary outcomes:
measure: To determine the contraceptive efficacy of progestin only patch when used over 13 cycles
timeFrame: 13 cycles [of 4 weeks (28 days)
Secondary outcomes:
measure: To determine the efficacy in obese population (Body mass index (BMI) ≥30.0 kg/m2)
timeFrame: 13 cycles [of 4 weeks (28 days)
measure: To determine the efficacy in non-obese population (Body mass index (BMI) <30.0 kg/m2)
timeFrame: 13 cycles [of 4 weeks (28 days)
measure: Cycle-wise and cumulative pregnancy rates over 1 year
timeFrame: 13 cycles [of 4 weeks (28 days)
measure: Method failure PI
timeFrame: 13 cycles [of 4 weeks (28 days)
measure: Incidence of adverse events and serious adverse events
timeFrame: 13 cycles [of 4 weeks (28 days)
measure: Incidence of application site reactions
timeFrame: 13 cycles [of 4 weeks (28 days)
measure: Unscheduled bleeding
timeFrame: 13 cycles [of 4 weeks (28 days)
measure: Adhesion performance
timeFrame: 13 cycles [of 4 weeks (28 days)
measure: progestin plasma concentrations
timeFrame: 5 cycles [of 4 weeks (28 days)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Dothan
country: United States
facility: SEC Clinical Research
state: Alabama
city: Mobile
country: United States
facility: AMR Mobile
state: Alabama
city: Mobile
country: United States
facility: Velocity Clinical Research
state: Alabama
city: Phoenix
country: United States
facility: Velocity Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials
state: Arizona
city: Huntington Park
country: United States
facility: Velocity Clinical Research Santa Ana
state: California
city: Los Angeles
country: United States
facility: Essential Access Health
state: California
city: San Diego
country: United States
facility: Women's Health Care Research Corp
state: California
city: San Diego
country: United States
facility: WR-Medical Center For Clinical Research
state: California
city: Fort Myers
country: United States
facility: AMR Fort Myers
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Leesburg
country: United States
facility: OB GYN Associates of Mid Florida P.A.
state: Florida
city: Miami
country: United States
facility: Genoma Research Group
state: Florida
city: Miami
country: United States
facility: Spotlight Research Center
state: Florida
city: Miami
country: United States
facility: New Age Med Research Corp
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare, LLC
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research Center
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Savannah
country: United States
facility: Javarra and Privia Med
state: Georgia
city: Idaho Falls
country: United States
facility: Leavitt ClinResearch
state: Idaho
city: Idaho Falls
country: United States
facility: Women's Healthcare Associates P.A.
state: Idaho
city: Newton
country: United States
facility: AMR Newton
state: Kansas
city: Lexington
country: United States
facility: AMR Lexington
state: Kentucky
city: Covington
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: Covington
country: United States
facility: Velocity Clinical Research
state: Louisiana
city: Lafayette
country: United States
facility: Velocity Clinical Research
state: Louisiana
city: Marrero
country: United States
facility: PraetorianPharmaResearch LLC
state: Louisiana
city: Metairie
country: United States
facility: Southern Clinical Research Associates
state: Louisiana
city: New Orleans
country: United States
facility: Velocity Clinical Research New Orleans
state: Louisiana
city: Saginaw
country: United States
facility: Valley OBGYN Clinic PC
state: Michigan
city: Kansas City
country: United States
facility: Alliance for Multispecialty Research
state: Missouri
city: Las Vegas
country: United States
facility: Essential Women's Health
state: Nevada
city: Marlton
country: United States
facility: CenExel Hassman Research Institute
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinic Trials Inc
state: New Mexico
city: Albuquerque
country: United States
facility: Bosque Women's Care
state: New Mexico
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Beachwood
country: United States
facility: Velocity Clinical Research
state: Ohio
city: Philadelphia
country: United States
facility: Clinical Research Philadelphia
state: Pennsylvania
city: Euless
country: United States
facility: Cedar Health Research, LLC
state: Texas
city: Fort Worth
country: United States
facility: Helios Clinical Research
state: Texas
city: Frisco
country: United States
facility: ACRC Trials
state: Texas
city: Houston
country: United States
facility: Javara
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network LLC
state: Texas
city: Rowlett
country: United States
facility: Javara
state: Texas
city: Stephenville
country: United States
facility: Stephenville Medical and Surgical Clinic
state: Texas
city: Sugar Land
country: United States
facility: Javara
state: Texas
city: Weatherford
country: United States
facility: Helios Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Norfolk
country: United States
facility: AMR Norfolk
state: Virginia
city: Seattle
country: United States
facility: Seattle Clinical Research Center
state: Washington
Study officials:
References: