Study of the contraceptive efficacy, cycle control, safety, and tolerability of MR-100A-01 in approxmiately 1200 women for up to 13 cycles
MR-100A-01 is a TDS of norelgestromin 4.86 mg/ethinyl estradiol 0.264 mg. This study will evaluate the contraceptive efficacy, cycle control, safety, and tolerability of MR-100A-01.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
1,320
Transdermal contraceptive delivery system
Contraceptive Efficacy of MR-100A-01 When Used Over Thirteen 28-day Cycles in Healthy, Post-menarcheal, Premenopausal, Heterosexually Active Female Subjects of Childbearing Potential Who Are at Least 16 Years of Age and at Risk of Pregnancy
The Pearl Index, defined as the number of pregnancies per 100 women years, was calculated as: Pearl Index = (1300×number of on-treatment pregnancies)/number of evaluable cycles. Evaluable cycles were defined as the complete or incomplete 28-day cycles in which vaginal intercourse occurred and in which no back-up contraception was used based on the electronic diary data, unless a pregnancy occurred in such a cycle.
Time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)
Cumulative Probability of Pregnancy at the End of Cycle 13
Cumulative pregnancy rates over 1 year evaluated using life table analysis
Time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)
Method Failure Pearl Index (PI)
The method failure PI is defined as PI among all complete or incomplete on therapy cycles in which intercourse occurred and protocol guidelines for patch applications were appropriately followed and without any major protocol deviations
Time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)
Incidence of Treatment Emergent Adverse Events (TEAEs)
A summary of the count and percentage of subjects (2%) reporting a TEAE
Time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)
Incidence of Serious Adverse Events (SAEs)
A summary of count and percentage of subjects reporting a Treatment emergent SAE
Time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)
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Number of Participants Reported Application Site Disorder
Number of participants reported Application site disorder which were treatment emergent adverse events (TEAE)
Time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)
Number of Days of Unscheduled Bleeding/and or Spotting
The observed number of days of unscheduled bleeding/and or spotting
Time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)
Number of Bleeding and/or Spotting Episodes
Number of Bleeding and/or Spotting episodes
Time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)
Proportion of Subjects Reporting Unscheduled Bleeding/and or Spotting Episodes
Incidences (percentage of subjects) of unscheduled bleeding and/or spotting episodes within each cycle
Time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)
Adhesion Performance as Measured by Adhesion Scores [Patch Adhesion]
The descriptive figures of adhesion performance reported by subjects in their e-Diary on all days except during the patch-free week on the following 5-point scale. Score 0 indicates best adhesion and score 4 indicates worst adhesion. Higher score indicates poor adhesion. Self-Reported Scoring System of Patch Adhesion Assessment Score 0 - The patch has essentially no lift off the skin (≥90% adhered) Score 1 - Only some edges of the patch lift off the skin (≥75% to \<90% adhered) Score 2 - Less than half of the patch lifts off the skin (≥50% to \<75% adhered) Score 3 - The patch is not detached, but more than half of it lifts off the skin without falling off (\>0% to \<50% adhered) Score 4 - The patch is detached and is completely off the skin (0% adhered)
Time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)