Direct Helpers Research Center | Hialeah, FL
Status and phase
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About
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.
Full 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]).
Enrollment
Sex
Ages
Volunteers
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
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
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
Subjects must agree to not use any secondary (eg, spermicides) or emergency contraceptive methods during the study period
Subjects must not be enrolled or plan to enroll in any other clinical study during the study period
Subjects must be willing to use the study drug (LPRI-CF113) for 13 (28-day) medication cycles, and be willing to use the provided diary
Subjects must generally be in good physical and mental health based on a medical history and a physical examination performed by the Investigator at screening
Exclusion criteria
PART A:
The subject is pregnant at the time of screening
The subject has a desire to become pregnant at the time of screening
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:
The subject at the time of screening has a history of primary amenorrhea or secondary amenorrhea (with or without known etiology)
The subject has a current male sexual partner with a history of infertility, vasectomy, or bilateral orchiectomy
The subject has an abnormal Pap smear finding of low-grade squamous intraepithelial lesion or higher at screening or 6 months prior to screening. Subjects <21 years of age at screening do not require a Pap smear
The subject has a history of uncontrolled medical illness (eg, the subject has an uncontrolled thyroid disorder and is not on a stable treatment regimen for 2 or more months)
The subject has a history of jaundice while taking hormonal contraceptives
The subject has a history of alcohol or substance use disorder within 12 months prior to screening. Alcohol abuse is defined as typical consumption of 14 or more alcoholic drinks weekly
The subject has a history or current evidence of clinically significant psychiatric illness, such as major depression or schizophrenia, that in the opinion of the Investigator contraindicates participation in the study
The subject has surgical procedures scheduled to occur during the study that would preclude use of contraceptives or require withdrawal of contraceptives
The subject has a history of an inherited or acquired disorder that predisposes the subject to venous or arterial thromboembolism (eg, factor V Leiden mutation, prothrombin mutation, presence of antiphospholipid antibodies)
The subject has received an investigational product within 3 months prior to screening
The subject has a history of using or currently uses any medications known to interfere with the efficacy of hormonal contraceptives, or other prohibited medications or products
Medications known to reduce the efficacy of hormonal contraceptives:
Other prohibited medications or products:
The subject has a history of severe or critical Coronavirus Disease 2019 (COVID-19) or has been hospitalized for COVID-19 within 3 months prior to screening
The subject has any ongoing condition or history of medical illness that in the opinion of the Investigator may jeopardize the conduct of the study or impact screening
The subject is employed by the Sponsor, the Contract Research Organization (CRO), or the clinical facility (permanent, temporary contract worker, or designee responsible for the conduct of the study), or is a family member (spouse, parent, sibling, or child) of the Sponsor, CRO, or clinical facility employee
The subject has a known contraindication or hypersensitivity to ingredients or excipients of the study drug (LPRI-CF113)
The subject has a history of or is currently being treated for any of the following:
PART B:
The subject is <18 years of age, inclusive
The subject has a BMD Z-score of -1.5 at or lower at screening
The subject has a history of low-trauma fracture (eg, fracture from a fall from standing height). This does not include fractures of the fingers, toes, or skull
The subject has a history of medical conditions or procedures associated with low BMD. This includes the following:
The subject has a history of chronic (3 or more months) use within 12 months of screening of the following medications known to increase BMD:
The subject has a history of chronic (3 or more months) use within 12 months of screening of the following medications known to decrease BMD:
The subject has any of the following that may preclude accurate BMD measurement by DXA scan:
Primary purpose
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Interventional model
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1,009 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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