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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
1,630
MR-130A-01 transdermal system, patch to be used for female contraception
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.
Time frame: 13 cycles [of 4 weeks (28 days)
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).
Time frame: 13 cycles [of 4 weeks (28 days)
To determine the efficacy in non-obese population (Body mass index (BMI) <30.0 kg/m2)
Assessment of PI in non-obese population (BMI \<30.0 kg/m2).
Time frame: 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.
Time frame: 13 cycles [of 4 weeks (28 days)
Method failure PI
Assessment of method failure PI.
Time frame: 13 cycles [of 4 weeks (28 days)
Incidence of adverse events and serious adverse events
Assessment of adverse events and serious adverse events.
Time frame: 13 cycles [of 4 weeks (28 days)
Incidence of application site reactions
Assessment of application site reactions.
Time frame: 13 cycles [of 4 weeks (28 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
SEC Clinical Research
Dothan, Alabama, United States
AMR Mobile
Mobile, Alabama, United States
Velocity Clinical Research
Mobile, Alabama, United States
Velocity Clinical Research
Phoenix, Arizona, United States
Precision Trials
Phoenix, Arizona, United States
Velocity Clinical Research Santa Ana
Huntington Park, California, United States
Essential Access Health
Los Angeles, California, United States
Women's Health Care Research Corp
San Diego, California, United States
WR-Medical Center For Clinical Research
San Diego, California, United States
...and 46 more locations
Unscheduled bleeding
Assessment of number of episode and days of unscheduled bleeding, proportion of participants reporting unscheduled bleeding.
Time frame: 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.
Time frame: 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.
Time frame: 5 cycles [of 4 weeks (28 days)