Phase
Condition
N/ATreatment
Transdermal system containing progestin
Clinical Study ID
Ages > 16 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy, post-menarcheal and premenopausal women at risk of pregnancy who are atleast 16 years of age.
Desires to avoid pregnancy, is seeking to use hormonal contraception for at least 1year.
Has negative UPT results at screening and at enrollment visits.
Has normal, regular menstrual cycles that are between 21 and 35 days in durationover the last 6 months.
Engages in regular heterosexual vaginal intercourse (at least once per cycle), witha partner who is not known to be sub fertile or infertile.
Agrees not to use other contraceptives or other methodology to prevent pregnancyduring the study.
Able to understand and voluntarily provide written informed consent or assent (ifthe participant is adolescent prior to undergoing any trial related procedure) toparticipate in the study.
Exclusion
Exclusion Criteria:
Known or suspected pregnancy or planning pregnancy during next 12 months.
Participants with known hypersensitivity or intolerance to progestins, or anycomponents of the progestin patch.
History or presence of dermal sensitivity to medicated patches or to topicalapplications including bandages, surgical tape.
Known infertility (current or known history) or history of sterilization in eitherpartner.
Received injectable hormonal contraceptive therapy within 10 months of studyenrollment.
Current use of hormonal contraceptive implants.
Has non-hormonal or hormonal intrauterine device (IUD) in place; or has had a recentIUD removal without one spontaneous menses after removal prior to the date ofenrollment.
Recent surgical or medical abortion, miscarriage, ectopic pregnancy, or vaginal orcesarean delivery.
Participants lactating at the time of screening into the study or has occurrence ofless than 3 regular menstrual cycles after cessation of lactation.
Anticipates routine use of condoms or any other form of back-up contraception forprotection from sexually transmitted infections during the study or for emergencycontraception.
Participants having a known contraindication to progestin-only contraception.
Known or suspected progestin sensitive malignant or premalignant conditionsincluding but not limited to carcinoma of endometrium, ovary, or fallopian tubes.
Skin abnormality (e.g., tattoo or scar) at all possible application sites.
Long-term treatment with drugs or herbal products that are moderate/strong inducersor inhibitors of CYP3A4.
Has uncontrolled thyroid disorder (thyrotoxicosis or myxedema).
Has diagnosis of hereditary angioedema.
Participants with abnormal significant liver function tests as measured by liverfunction tests
Has a significantly abnormal cervical cancer screening test.
Participants with chlamydial or gonorrheal infection at screening.
Has unexplained vaginal bleeding within the past 6 months or any abnormal bleedingwhich is expected to recur during the study.
Study Design
Study Description
Connect with a study center
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama 35235
United StatesActive - Recruiting
SEC Clinical Research
Dothan, Alabama 36305
United StatesActive - Recruiting
AMR Mobile
Mobile, Alabama 36608
United StatesActive - Recruiting
Velocity Clinical Research
Mobile, Alabama 36608
United StatesActive - Recruiting
Precision Trials
Phoenix, Arizona 85032
United StatesActive - Recruiting
Velocity Clinical Research
Phoenix, Arizona 85006
United StatesActive - Recruiting
Velocity Clinical Research Santa Ana
Huntington Park, California 90255
United StatesActive - Recruiting
Essential Access Health
Los Angeles, California 90017
United StatesActive - Recruiting
WR-Medical Center For Clinical Research
San Diego, California 92120
United StatesActive - Recruiting
Women's Health Care Research Corp
San Diego, California 92111
United StatesActive - Recruiting
AMR Fort Myers
Fort Myers, Florida 33912
United StatesActive - Recruiting
Altus Research
Lake Worth, Florida 33461
United StatesActive - Recruiting
OB GYN Associates of Mid Florida P.A.
Leesburg, Florida 34748
United StatesActive - Recruiting
Clinical Investigator Site
Miami, Florida 33186
United StatesSite Not Available
Genoma Research Group
Miami, Florida 33173
United StatesActive - Recruiting
New Age Med Research Corp
Miami, Florida 33186
United StatesActive - Recruiting
Spotlight Research Center
Miami, Florida 33176
United StatesActive - Recruiting
Sensible Healthcare, LLC
Ocoee, Florida 34761
United StatesActive - Recruiting
Innovation Medical Research Center
Palmetto Bay, Florida 33157
United StatesActive - Recruiting
Clinical Research Center of Florida
Pompano Beach, Florida 33060
United StatesActive - Recruiting
Javarra and Privia Med
Savannah, Georgia 31406
United StatesActive - Recruiting
Leavitt ClinResearch
Idaho Falls, Idaho 83404
United StatesActive - Recruiting
Women's Healthcare Associates P.A.
Idaho Falls, Idaho 83404
United StatesActive - Recruiting
AMR Newton
Newton, Kansas 67114
United StatesActive - Recruiting
AMR Lexington
Lexington, Kentucky 40509
United StatesActive - Recruiting
Clinical Trials Management, LLC
Covington, Louisiana 70433
United StatesActive - Recruiting
Velocity Clinical Research
Covington, Louisiana 70433
United StatesActive - Recruiting
Velocity Clinical Research
Lafayette, Louisiana 70508
United StatesActive - Recruiting
PraetorianPharmaResearch LLC
Marrero, Louisiana 70072
United StatesActive - Recruiting
Southern Clinical Research Associates
Metairie, Louisiana 70001
United StatesActive - Recruiting
Velocity Clinical Research New Orleans
New Orleans, Louisiana 70119
United StatesActive - Recruiting
Valley OBGYN Clinic PC
Saginaw, Michigan 48602
United StatesActive - Recruiting
Alliance for Multispecialty Research
Kansas City, Missouri 64114
United StatesActive - Recruiting
Essential Women's Health
Las Vegas, Nevada 89113
United StatesActive - Recruiting
CenExel Hassman Research Institute
Marlton, New Jersey 08053
United StatesActive - Recruiting
Albuquerque Clinic Trials Inc
Albuquerque, New Mexico 87102
United StatesActive - Recruiting
Bosque Women's Care
Albuquerque, New Mexico 87109
United StatesActive - Recruiting
M3 Wake Research, Inc.
Raleigh, North Carolina 27612
United StatesActive - Recruiting
Velocity Clinical Research
Beachwood, Ohio 44122
United StatesActive - Recruiting
Velocity Clinical Research
Cleveland, Ohio 44122
United StatesSite Not Available
Clinical Research Philadelphia
Philadelphia, Pennsylvania 19114
United StatesActive - Recruiting
Cedar Health Research, LLC
Euless, Texas 76040
United StatesActive - Recruiting
Helios Clinical Research
Fort Worth, Texas 76104
United StatesActive - Recruiting
ACRC Trials
Frisco, Texas 75033
United StatesActive - Recruiting
Clinical Trial Network LLC
Houston, Texas 77074
United StatesActive - Recruiting
Javara
Houston, Texas 77054
United StatesActive - Recruiting
Javara
Rowlett, Texas 75088
United StatesActive - Recruiting
Stephenville Medical and Surgical Clinic
Stephenville, Texas 76401
United StatesActive - Recruiting
Javara
Sugar Land, Texas 77478
United StatesActive - Recruiting
Helios Clinical Research
Weatherford, Texas 76086
United StatesActive - Recruiting
Wasatch Clinical Research
Salt Lake City, Utah 84102
United StatesActive - Recruiting
AMR Norfolk
Norfolk, Virginia 23502
United StatesActive - Recruiting
Seattle Clinical Research Center
Seattle, Washington 98104
United StatesActive - Recruiting
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