Efficacy, Safety, and Tolerability of LPRI-CF113 as an Oral Contraceptive in Females

Completed · Phase 3

Conditions studied: Contraception, Change in Bone Mineral Density

In brief

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.

Key facts

Study ID

NCT05461573

Run by

Insud Pharma

People needed

1542

Starts

2022-08-02

Expected to finish

2025-05-27

Last updated by the study team

2025-10-08

Who can join

Age: 13 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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
• Note: Breastfeeding women can be included 6 weeks after delivery irrespective of menstrual cycles post-delivery
• 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

You may not qualify if…

• PART A:
• 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
• The subject at the time of screening has a history of primary amenorrhea or secondary amenorrhea (with or without known etiology)
• Note: Primary amenorrhea is defined as no menarche by 16 years of age with normal secondary sexual characteristics
• Note: Secondary amenorrhea is defined as the absence of menses for 3 months in the setting of previously normal (ie, regular) menstruation
• 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
• Note: Human papilloma virus (HPV) testing, by polymerase chain reaction (PCR), will be performed only in the case of atypical squamous cells of undetermined significance (ASC-US). Subjects with ASC-US can be included if negative for high-risk HPV strains
• Note: A historical Pap smear may be used for eligibility if performed within the past 6 months with results available
• 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
• Note: One drink of alcohol is equivalent to ½ pint of beer (285 mL), 1 glass of spirits (25 mL), or 1 glass of wine (125 mL)
• 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)

Where it is running

• Alabama Clinical Therapeutics, LLC — Alabaster, Alabama, United States
• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
• Del Sol Research Management — Tucson, Arizona, United States
• Eclipse Clinical Research — Tucson, Arizona, United States
• Cornerstone Research Institute - Longwood — Altamonte Springs, Florida, United States
• Encore Medical Research of Boynton Beach LLC. — Boynton Beach, Florida, United States
• Women's Medical Research Group — Clearwater, Florida, United States
• Direct Helpers Research Center — Hialeah, Florida, United States
• Inpatient Research Clinic, LLC — Hialeah, Florida, United States
• Vital Pharma Research, Inc. — Hialeah, Florida, United States
• Encore Medical Research, LLC — Hollywood, Florida, United States
• Global Research Associates — Homestead, Florida, United States
• Altus Research — Lake Worth, Florida, United States
• Florida International Medical Research — Miami, Florida, United States
• New Age Medical Research Corporation — Miami, Florida, United States
• SJ Research Institute — Miami, Florida, United States
• Segal Institute for Clinical Research — North Miami, Florida, United States
• American Research Centers of Florida — Pembroke Pines, Florida, United States
• Comprehensive Clinical Trials — West Palm Beach, Florida, United States
• Encore Medical Research of Weston LLC — Weston, Florida, United States
• Fellows Research Alliance — Savannah, Georgia, United States
• Clinical Research Prime — Idaho Falls, Idaho, United States
• Leavitt Clinical Research — Idaho Falls, Idaho, United States
• Rosemark WomenCare Specialists — Idaho Falls, Idaho, United States
• Praetorian Pharmaceutical Research — Marrero, Louisiana, United States

Full record on ClinicalTrials.gov

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