Oral Contraceptive for Birth Control

Recruiting in Palo Alto (17 mi)

+24 other locations

Age: < 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Insud Pharma

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for healthy, sexually active females aged 13-45 who are not pregnant or trying to become pregnant and do not plan to use other contraceptives. They must have regular menstrual cycles and a BMI of at least 18 kg/m2. Participants should be willing to engage in intercourse without additional contraception methods and agree to take the study drug for over a year. Those with certain health conditions or taking medications that affect bone density are excluded.

Inclusion Criteria

Subjects must have a BMI of 18 kg/m2 or higher

Subjects must not be enrolled or plan to enroll in any other clinical study during the study period

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

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Exclusion Criteria

My recent ultrasound showed unusual results.

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

My recent Pap smear showed abnormal cells.

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Treatment Details

Interventions

Drospirenone (Progestin)

Trial OverviewThe trial tests LPRI-CF113's effectiveness as an oral contraceptive (Part A) and its impact on bone mineral density, particularly in the lumbar spine after one year (Part B). It also examines safety and tolerability, along with effects on bone turnover at various body sites.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Part B - The effect of LPRI-CF113 on bone mineral density in a subgroup age 18-45Experimental Treatment1 Intervention

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.

Group II: Part A - An investigation of the efficacy, safety, and tolerability of LPRI-CF113Experimental Treatment1 Intervention

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.