Transdermal system containing progestin: MR-130A-01 transdermal system, patch to be used for female contraception
Study 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.
Eligibility
Sex
FEMALE
Min age
16 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
To determine the contraceptive efficacy of progestin only patch when used over 13 cycles — 13 cycles [of 4 weeks (28 days) 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.
Trial sites (56)
Facility
City
Region
Status
Alabama Clinical Therapeutics, LLC
Birmingham
Alabama
SEC Clinical Research
Dothan
Alabama
AMR Mobile
Mobile
Alabama
Velocity Clinical Research
Mobile
Alabama
Velocity Clinical Research
Phoenix
Arizona
Precision Trials
Phoenix
Arizona
Velocity Clinical Research Santa Ana
Huntington Park
California
Essential Access Health
Los Angeles
California
Women's Health Care Research Corp
San Diego
California
WR-Medical Center For Clinical Research
San Diego
California
Altus Research
Lake Worth
Florida
OB GYN Associates of Mid Florida P.A.
Leesburg
Florida
Genoma Research Group
Miami
Florida
Spotlight Research Center
Miami
Florida
New Age Med Research Corp
Miami
Florida
Sensible Healthcare, LLC
Ocoee
Florida
Innovation Medical Research Center
Palmetto Bay
Florida
Clinical Research Center of Florida
Pompano Beach
Florida
CenExel iResearch LLC
Decatur
Georgia
CenExel Savannah
Savannah
Georgia
Javarra and Privia Med
Savannah
Georgia
Leavitt ClinResearch
Idaho Falls
Idaho
Women's Healthcare Associates P.A.
Idaho Falls
Idaho
AMR Newton
Newton
Kansas
AMR Lexington
Lexington
Kentucky
Clinical Trials Management, LLC
Covington
Louisiana
Velocity Clinical Research
Covington
Louisiana
Velocity Clinical Research
Lafayette
Louisiana
PraetorianPharmaResearch LLC
Marrero
Louisiana
Southern Clinical Research Associates
Metairie
Louisiana
Velocity Clinical Research New Orleans
New Orleans
Louisiana
Valley OBGYN Clinic PC
Saginaw
Michigan
Velocity Clinical Research
Gulfport
Mississippi
Alliance for Multispecialty Research
Kansas City
Missouri
M3 Wake Research Inc
Las Vegas
Nevada
Excel Clinical Research
Las Vegas
Nevada
Essential Women's Health
Las Vegas
Nevada
CenExel Hassman Research Institute
Marlton
New Jersey
Albuquerque Clinic Trials Inc
Albuquerque
New Mexico
Bosque Women's Care
Albuquerque
New Mexico
+ 16 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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