A Phase 3, Multi-Center, Non-Comparative Study to Evaluate the Contraceptive Efficacy, Safety, and Tolerability of LPRI-CF113 Administered Orally for 13 Medication Cycles
Overview
- Phase
- Phase 3
- Intervention
- Drospirenone
- Conditions
- Contraception
- Sponsor
- Insud Pharma
- Enrollment
- 1542
- Locations
- 46
- Primary Endpoint
- Part A (Efficacy Assessment): Number of pregnancies in subjects ≤35 years of age (at the time of screening).
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief Summary
This study will be in two parts, Part A and Part B. The primary objective of Part A is to evaluate the contraceptive efficacy of LPRI-CF113. The secondary objective of Part A is to evaluate the safety and tolerability of LPRI-CF113. The primary objective of Part B is to evaluate the impact of LPRI-CF113 on bone mineral density (BMD) at the lumbar spine (L1-L4) after 12 months (13 medication cycles). The secondary objective of Part B is to evaluate the impact of LPRI-CF113 on BMD and bone turnover after 12 months (13 medication cycles) at the femoral neck, total hip, and total body.
Detailed Description
This is a Phase 3, prospective, multi-center, open-label, non-comparative study in female subjects 13 to 45 years of age (inclusive) to determine the efficacy, safety, and tolerability of LPRI-CF113 administered orally for 13 (28-day) medication cycles (Part A). Healthy, sexually active female subjects of childbearing potential, who present to the clinic seeking contraception, will be enrolled in the study. Part B will be an investigation of bone mineral density (BMD) at the lumbar spine and BMD and bone turnover at the femoral neck, total hip, and total body. Part B will consist of a subgroup of subjects enrolled in Part A (i.e., subjects that meet all of Part A inclusion criteria and none of Part A AND Part B exclusion criteria) who are 18 to 45 years of age (inclusive at the time of screening). BMD will be assessed by dual-energy X-ray absorptiometry (DXA) scan. The study duration (Parts A and B) for each subject will be up to approximately 404 days (28 days \[screening\] + 376 days \[Treatment and Follow-up Period\]), unless the subject meets criteria for the extended Part B Follow-up, in which the duration will be approximately 769 days (28 days \[screening\] + 376 days \[Treatment and Follow-up Period\] + 365 days \[extended Part B Follow up\]).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must be willing and able to provide written informed consent (for adults) or assent (for adolescents \<18 years of age) and comply with all study procedures, prohibitions, restrictions, and scheduled visits
- •Subjects must be female, healthy, sexually active, postmenarcheal, premenopausal, and of childbearing potential, between 13 and 45 years of age (inclusive at the time of screening) and at risk for pregnancy
- •Note: Childbearing potential is defined as subjects who are ovulating, premenopausal, and not surgically sterile (ie, have not undergone hysterectomy, salpingectomy, or bilateral oophorectomy). Subjects that have undergone unilateral oophorectomy will not be considered surgically sterile and may be included in the study
- •Note: Only subjects 18 to 45 years of age (inclusive at the time of screening) are eligible for inclusion in Part B
- •Subjects must be willing to have vaginal intercourse (with a genetically male partner) throughout the Treatment Period (ie, during each medication cycle) without using a secondary (eg, spermicides) or emergency method of contraception
- •Subjects must have a BMI of 18 kg/m2 or higher
- •Subjects must have a systolic blood pressure of 159 mmHg or lower and a diastolic blood pressure of 99 mmHg or lower
- •Note: The median of 3 blood pressure measurements will be used for this criterion
- •Note: Subjects are required to rest for 5 minutes prior to the first blood pressure measurement and for 1 minute between subsequent measurements. Measurements done without appropriate preparation of the subject (excluding caffeine use, smoking, or excessive physical activity) should not be considered, and the measurement should be repeated upon appropriate preparation of the subject
- •Subjects must be regularly menstruating (with cycle length between 21 and 35 days) for at least 3 months prior to the signing of the Informed Consent Form
Exclusion Criteria
- •The subject is pregnant at the time of screening
- •The subject has a desire to become pregnant at the time of screening
- •Note: The subject will be asked if she has a desire for pregnancy at screening (and at each study visit). If a positive answer is given at screening, the subject will be excluded
- •The subject plans regular concomitant use of barrier contraceptive methods, spermicides, intrauterine device, other contraceptive measures, prohibited medications, and drugs contraindicated for study drug
- •The subject has an abnormal and clinically significant finding on pelvic, breast, or ultrasound examination at screening based on the judgment of the Investigator
- •The subject has an abnormal and clinically significant finding on physical examination, clinical laboratory assessments (chemistry, hematology, urinalysis), or 12-lead ECG assessment based on the judgment of the Investigator
- •The subject has had less than 3 menstrual cycles after discontinuing dosing of depot medroxyprogesterone acetate (Depo-Provera®) or any combined injectable contraceptive (eg, Cyclofem®) prior to consent/assent. Those with spontaneous menses while on injectable contraceptive will be considered for inclusion
- •The subject has received any of the following:
- •A progestin-releasing intra-uterine device or contraceptive implant within 2 months prior to screening or
- •A beta-human chorionic gonadotropin (β-hCG) or co-medication containing β-hCG within 1 month prior to screening
Arms & Interventions
Part A - An investigation of the efficacy, safety, and tolerability of LPRI-CF113
All subjects enrolled in the study will participate in Part A of the study. Part A of the study will investigate the efficacy, safety, and tolerability of LPRI-CF113.
Intervention: Drospirenone
Part B - The effect of LPRI-CF113 on bone mineral density in a subgroup age 18-45
A subgroup of subjects from Part A that are age 18-45 and without further exclusion criteria to Part B will be enrolled in Part B of the study. Part B of the study will investigate the effects of LPRI-CF113 on bone mineral density.
Intervention: Drospirenone
Outcomes
Primary Outcomes
Part A (Efficacy Assessment): Number of pregnancies in subjects ≤35 years of age (at the time of screening).
Time Frame: 12 months
Calculated by Pearl Index.
Secondary Outcomes
- Part A (Efficacy Assessment): Pregnancy ratio from evaluable cycles, exposure cycles, and perfect cycles in subjects ≤35 years of age.(12 months)
- Part A (Efficacy Assessment): Number of pregnancies from exposure cycles in subjects ≤35 years of age.(12 months)
- Part A (Efficacy Assessment): Pregnancy ratio in all subjects.(12 months)
- Part A (Efficacy Assessment): Number of pregnancies from exposure cycles, method failures, and evaluable cycles in all subjects.(12 months)
- Part A (Efficacy Assessment): Number of pregnancies from exposure cycles, method failures, and evaluable cycles in subjects >35 years of age.(12 months)
- Part A (Efficacy Assessment): Number of pregnancies from method failures in subjects ≤35 years of age.(12 months)
- Part A (Efficacy Assessment): Pregnancy ratio in subjects >35 years of age.(12 months)