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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| This is a single-arm study. | Experimental | The study patch is a transdermal system that contains the active ingredient progestin. This study is an open-label, single-arm study. This means that all participants in the study will receive the study patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transdermal system containing progestin | Drug | MR-130A-01 transdermal system, patch to be used for female contraception |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the contraceptive efficacy of progestin only patch when used over 13 cycles | 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. | 13 cycles [of 4 weeks (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the efficacy in obese population (Body mass index (BMI) ≥30.0 kg/m2) | Assessment of PI in obese population (Body mass index (BMI) ≥30.0 kg/m2). | 13 cycles [of 4 weeks (28 days) |
| To determine the efficacy in non-obese population (Body mass index (BMI) <30.0 kg/m2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | United States | ||
| SEC Clinical Research |
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Assessment of PI in non-obese population (BMI <30.0 kg/m2). |
| 13 cycles [of 4 weeks (28 days) |
| Cycle-wise and cumulative pregnancy rates over 1 year | Assessment of cycle-wise and cumulative pregnancy rates over 1 year using life table analysis. | 13 cycles [of 4 weeks (28 days) |
| Method failure PI | Assessment of method failure PI. | 13 cycles [of 4 weeks (28 days) |
| Incidence of adverse events and serious adverse events | Assessment of adverse events and serious adverse events. | 13 cycles [of 4 weeks (28 days) |
| Incidence of application site reactions | Assessment of application site reactions. | 13 cycles [of 4 weeks (28 days) |
| Unscheduled bleeding | Assessment of number of episode and days of unscheduled bleeding, proportion of participants reporting unscheduled bleeding. | 13 cycles [of 4 weeks (28 days) |
| Adhesion performance | Assessment of patch adhesion performance as measured by 'Self-Reported Scoring System of Patch Adhesion Assessment Scale' Scores range from 0 to 4 where score 0 indicates the patch has essentially no lift off the skin and score 4 indicates the patch is detached and is completely off the skin. | 13 cycles [of 4 weeks (28 days) |
| progestin plasma concentrations | Evaluation of progestin exposure in the subset of participants. PK samples for evaluation of progestin concentrations will be collected during cycles 2 and 5, for population PK and exposure-response analysis. | 5 cycles [of 4 weeks (28 days) |
| Dothan |
| Alabama |
| 36305 |
| United States |
| AMR Mobile | Mobile | Alabama | 36608 | United States |
| Velocity Clinical Research | Mobile | Alabama | 36608 | United States |
| Velocity Clinical Research | Phoenix | Arizona | 85006 | United States |
| Precision Trials | Phoenix | Arizona | 85032 | United States |
| Velocity Clinical Research Santa Ana | Huntington Park | California | 90255 | United States |
| Essential Access Health | Los Angeles | California | 90017 | United States |
| Women's Health Care Research Corp | San Diego | California | 92111 | United States |
| WR-Medical Center For Clinical Research | San Diego | California | 92120 | United States |
| Altus Research | Lake Worth | Florida | 33461 | United States |
| OB GYN Associates of Mid Florida P.A. | Leesburg | Florida | 34748 | United States |
| Genoma Research Group | Miami | Florida | 33173 | United States |
| Spotlight Research Center | Miami | Florida | 33176 | United States |
| New Age Med Research Corp | Miami | Florida | 33186 | United States |
| Sensible Healthcare, LLC | Ocoee | Florida | 34761 | United States |
| Innovation Medical Research Center | Palmetto Bay | Florida | 33157 | United States |
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | United States |
| CenExel iResearch LLC | Decatur | Georgia | 30030 | United States |
| CenExel Savannah | Savannah | Georgia | 31405 | United States |
| Javarra and Privia Med | Savannah | Georgia | 31406 | United States |
| Leavitt ClinResearch | Idaho Falls | Idaho | 83404 | United States |
| Women's Healthcare Associates P.A. | Idaho Falls | Idaho | 83404 | United States |
| AMR Newton | Newton | Kansas | 67114 | United States |
| AMR Lexington | Lexington | Kentucky | 40509 | United States |
| Clinical Trials Management, LLC | Covington | Louisiana | 70433 | United States |
| Velocity Clinical Research | Covington | Louisiana | 70433 | United States |
| Velocity Clinical Research | Lafayette | Louisiana | 70508 | United States |
| PraetorianPharmaResearch LLC | Marrero | Louisiana | 70072 | United States |
| Southern Clinical Research Associates | Metairie | Louisiana | 70001 | United States |
| Velocity Clinical Research New Orleans | New Orleans | Louisiana | 70119 | United States |
| Valley OBGYN Clinic PC | Saginaw | Michigan | 48602 | United States |
| Velocity Clinical Research | Gulfport | Mississippi | 39503 | United States |
| Alliance for Multispecialty Research | Kansas City | Missouri | 64114 | United States |
| M3 Wake Research Inc | Las Vegas | Nevada | 89106 | United States |
| Excel Clinical Research | Las Vegas | Nevada | 89109 | United States |
| Essential Women's Health | Las Vegas | Nevada | 89113 | United States |
| CenExel Hassman Research Institute | Marlton | New Jersey | 08053 | United States |
| Albuquerque Clinic Trials Inc | Albuquerque | New Mexico | 87102 | United States |
| Bosque Women's Care | Albuquerque | New Mexico | 87109 | United States |
| M3 Wake Research, Inc. | Raleigh | North Carolina | 27612 | United States |
| Velocity Clinical Research | Beachwood | Ohio | 44122 | United States |
| Clinical Research Philadelphia | Philadelphia | Pennsylvania | 19114 | United States |
| Cedar Health Research, LLC | Euless | Texas | 76040 | United States |
| Helios Clinical Research | Fort Worth | Texas | 76104 | United States |
| ACRC Trials | Frisco | Texas | 75033 | United States |
| Javara | Houston | Texas | 77054 | United States |
| Clinical Trial Network LLC | Houston | Texas | 77074 | United States |
| Javara | Rowlett | Texas | 75088 | United States |
| Stephenville Medical and Surgical Clinic | Stephenville | Texas | 76401 | United States |
| Javara | Sugarland | Texas | 77478 | United States |
| Helios Clinical Research | Weatherford | Texas | 76086 | United States |
| Wasatch Clinical Research | Salt Lake City | Utah | 84102 | United States |
| Tidewater Clinical Research | Norfolk | Virginia | 23052 | United States |
| AMR Norfolk | Norfolk | Virginia | 23502 | United States |
| Seattle Clinical Research Center | Seattle | Washington | 98104 | United States |