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 StatesSite Not Available
SEC Clinical Research
Dothan, Alabama 36305
United StatesSite Not Available
AMR Mobile
Mobile, Alabama 36608
United StatesSite Not Available
Velocity Clinical Research
Mobile, Alabama 36608
United StatesActive - Recruiting
Alabama Clinical Therapeutics, LLC
Birmingham 4049979, Alabama 4829764 35235
United StatesActive - Recruiting
SEC Clinical Research
Dothan 4059102, Alabama 4829764 36305
United StatesActive - Recruiting
AMR Mobile
Mobile 4076598, Alabama 4829764 36608
United StatesActive - Recruiting
Velocity Clinical Research
Mobile 4076598, Alabama 4829764 36608
United StatesActive - Recruiting
Precision Trials
Phoenix, Arizona 85032
United StatesActive - Recruiting
Velocity Clinical Research
Phoenix, Arizona 85006
United StatesSite Not Available
Precision Trials
Phoenix 5308655, Arizona 5551752 85032
United StatesActive - Recruiting
Velocity Clinical Research
Phoenix 5308655, Arizona 5551752 85006
United StatesActive - Recruiting
Velocity Clinical Research Santa Ana
Huntington Park, California 90255
United StatesSite Not Available
Essential Access Health
Los Angeles, California 90017
United StatesSite Not Available
WR-Medical Center For Clinical Research
San Diego, California 92120
United StatesActive - Recruiting
Women's Health Care Research Corp
San Diego, California 92111
United StatesSite Not Available
Velocity Clinical Research Santa Ana
Huntington Park 5358736, California 5332921 90255
United StatesActive - Recruiting
Essential Access Health
Los Angeles 5368361, California 5332921 90017
United StatesActive - Recruiting
WR-Medical Center For Clinical Research
San Diego 5391811, California 5332921 92120
United StatesActive - Recruiting
Women's Health Care Research Corp
San Diego 5391811, California 5332921 92111
United StatesActive - Recruiting
AMR Fort Myers
Fort Myers, Florida 33912
United StatesSite Not Available
Altus Research
Lake Worth, Florida 33461
United StatesSite Not Available
OB GYN Associates of Mid Florida P.A.
Leesburg, Florida 34748
United StatesSite Not Available
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 StatesSite Not Available
Spotlight Research Center
Miami, Florida 33176
United StatesActive - Recruiting
Sensible Healthcare, LLC
Ocoee, Florida 34761
United StatesSite Not Available
Innovation Medical Research Center
Palmetto Bay, Florida 33157
United StatesSite Not Available
Clinical Research Center of Florida
Pompano Beach, Florida 33060
United StatesSite Not Available
AMR Fort Myers
Fort Myers 4155995, Florida 4155751 33912
United StatesSite Not Available
Altus Research
Lake Worth 4161422, Florida 4155751 33461
United StatesActive - Recruiting
OB GYN Associates of Mid Florida P.A.
Leesburg 4161771, Florida 4155751 34748
United StatesActive - Recruiting
Genoma Research Group
Miami 4164138, Florida 4155751 33173
United StatesActive - Recruiting
New Age Med Research Corp
Miami 4164138, Florida 4155751 33186
United StatesActive - Recruiting
Spotlight Research Center
Miami 4164138, Florida 4155751 33176
United StatesActive - Recruiting
Sensible Healthcare, LLC
Ocoee 4166776, Florida 4155751 34761
United StatesActive - Recruiting
Innovation Medical Research Center
Palmetto Bay 4167634, Florida 4155751 33157
United StatesActive - Recruiting
Clinical Research Center of Florida
Pompano Beach 4169014, Florida 4155751 33060
United StatesSite Not Available
Javarra and Privia Med
Savannah, Georgia 31406
United StatesSite Not Available
CenExel iResearch LLC
Decatur 4191124, Georgia 4197000 30030
United StatesActive - Recruiting
CenExel Savannah
Savannah 4221552, Georgia 4197000 31405
United StatesActive - Recruiting
Javarra and Privia Med
Savannah 4221552, Georgia 4197000 31406
United StatesActive - Recruiting
Leavitt ClinResearch
Idaho Falls, Idaho 83404
United StatesSite Not Available
Women's Healthcare Associates P.A.
Idaho Falls, Idaho 83404
United StatesActive - Recruiting
Leavitt ClinResearch
Idaho Falls 5596475, Idaho 5596512 83404
United StatesActive - Recruiting
Women's Healthcare Associates P.A.
Idaho Falls 5596475, Idaho 5596512 83404
United StatesActive - Recruiting
AMR Newton
Newton, Kansas 67114
United StatesSite Not Available
AMR Newton
Newton 4276248, Kansas 4273857 67114
United StatesActive - Recruiting
AMR Lexington
Lexington, Kentucky 40509
United StatesSite Not Available
AMR Lexington
Lexington 4297983, Kentucky 6254925 40509
United StatesActive - Recruiting
Clinical Trials Management, LLC
Covington, Louisiana 70433
United StatesSite Not Available
Velocity Clinical Research
Covington, Louisiana 70433
United StatesActive - Recruiting
Velocity Clinical Research
Lafayette, Louisiana 70508
United StatesSite Not Available
PraetorianPharmaResearch LLC
Marrero, Louisiana 70072
United StatesSite Not Available
Southern Clinical Research Associates
Metairie, Louisiana 70001
United StatesSite Not Available
Velocity Clinical Research New Orleans
New Orleans, Louisiana 70119
United StatesSite Not Available
Clinical Trials Management, LLC
Covington 4321005, Louisiana 4331987 70433
United StatesActive - Recruiting
Velocity Clinical Research
Covington 4321005, Louisiana 4331987 70433
United StatesActive - Recruiting
Velocity Clinical Research
Lafayette 4330145, Louisiana 4331987 70508
United StatesActive - Recruiting
PraetorianPharmaResearch LLC
Marrero 4332628, Louisiana 4331987 70072
United StatesActive - Recruiting
Southern Clinical Research Associates
Metairie 4333177, Louisiana 4331987 70001
United StatesActive - Recruiting
Velocity Clinical Research New Orleans
New Orleans 4335045, Louisiana 4331987 70119
United StatesActive - Recruiting
Valley OBGYN Clinic PC
Saginaw, Michigan 48602
United StatesSite Not Available
Valley OBGYN Clinic PC
Saginaw 5007989, Michigan 5001836 48602
United StatesActive - Recruiting
Velocity Clinical Research
Gulfport 4428667, Mississippi 4436296 39503
United StatesActive - Recruiting
Alliance for Multispecialty Research
Kansas City, Missouri 64114
United StatesSite Not Available
Alliance for Multispecialty Research
Kansas City 4393217, Missouri 4398678 64114
United StatesActive - Recruiting
Essential Women's Health
Las Vegas, Nevada 89113
United StatesSite Not Available
Essential Women's Health
Las Vegas 5506956, Nevada 5509151 89113
United StatesActive - Recruiting
Excel Clinical Research
Las Vegas 5506956, Nevada 5509151 89109
United StatesActive - Recruiting
M3 Wake Research Inc
Las Vegas 5506956, Nevada 5509151 89106
United StatesActive - Recruiting
CenExel Hassman Research Institute
Marlton, New Jersey 08053
United StatesSite Not Available
CenExel Hassman Research Institute
Marlton 4502911, New Jersey 5101760 08053
United StatesActive - Recruiting
Albuquerque Clinic Trials Inc
Albuquerque, New Mexico 87102
United StatesSite Not Available
Bosque Women's Care
Albuquerque, New Mexico 87109
United StatesActive - Recruiting
Albuquerque Clinic Trials Inc
Albuquerque 5454711, New Mexico 5481136 87102
United StatesActive - Recruiting
Bosque Women's Care
Albuquerque 5454711, New Mexico 5481136 87109
United StatesActive - Recruiting
M3 Wake Research, Inc.
Raleigh, North Carolina 27612
United StatesSite Not Available
M3 Wake Research, Inc.
Raleigh 4487042, North Carolina 4482348 27612
United StatesActive - Recruiting
Velocity Clinical Research
Beachwood, Ohio 44122
United StatesSite Not Available
Velocity Clinical Research
Cleveland, Ohio 44122
United StatesSite Not Available
Velocity Clinical Research
Beachwood 5146711, Ohio 5165418 44122
United StatesActive - Recruiting
Clinical Research Philadelphia
Philadelphia, Pennsylvania 19114
United StatesSite Not Available
Clinical Research Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19114
United StatesActive - Recruiting
Cedar Health Research, LLC
Euless, Texas 76040
United StatesSite Not Available
Helios Clinical Research
Fort Worth, Texas 76104
United StatesSite Not Available
ACRC Trials
Frisco, Texas 75033
United StatesSite Not Available
Clinical Trial Network LLC
Houston, Texas 77074
United StatesSite Not Available
Javara
Houston, Texas 77054
United StatesActive - Recruiting
Javara
Rowlett, Texas 75088
United StatesSite Not Available
Stephenville Medical and Surgical Clinic
Stephenville, Texas 76401
United StatesSite Not Available
Javara
Sugar Land, Texas 77478
United StatesSite Not Available
Helios Clinical Research
Weatherford, Texas 76086
United StatesSite Not Available
Cedar Health Research, LLC
Euless 4689550, Texas 4736286 76040
United StatesActive - Recruiting
Helios Clinical Research
Fort Worth 4691930, Texas 4736286 76104
United StatesActive - Recruiting
ACRC Trials
Frisco 4692559, Texas 4736286 75033
United StatesActive - Recruiting
Clinical Trial Network LLC
Houston 4699066, Texas 4736286 77074
United StatesActive - Recruiting
Javara
Houston 4699066, Texas 4736286 77054
United StatesActive - Recruiting
Javara
Rowlett 4724194, Texas 4736286 75088
United StatesActive - Recruiting
Stephenville Medical and Surgical Clinic
Stephenville 4734350, Texas 4736286 76401
United StatesActive - Recruiting
Javara
Sugarland, Texas 4736286 77478
United StatesActive - Recruiting
Helios Clinical Research
Weatherford 4740364, Texas 4736286 76086
United StatesActive - Recruiting
Wasatch Clinical Research
Salt Lake City, Utah 84102
United StatesSite Not Available
Wasatch Clinical Research
Salt Lake City 5780993, Utah 5549030 84102
United StatesActive - Recruiting
AMR Norfolk
Norfolk, Virginia 23502
United StatesSite Not Available
AMR Norfolk
Norfolk 4776222, Virginia 6254928 23502
United StatesActive - Recruiting
Tidewater Clinical Research
Norfolk 4776222, Virginia 6254928 23052
United StatesActive - Recruiting
Seattle Clinical Research Center
Seattle, Washington 98104
United StatesSite Not Available
Seattle Clinical Research Center
Seattle 5809844, Washington 5815135 98104
United StatesActive - Recruiting

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