Evaluation of Contraceptive Efficacy, Safety and Tolerability of Oral Drospirenone 4 mg (LPRI‑CF113) Over 13 Cycles: Multicentre Open‑Label Single‑Arm Study

The primary objective is to demonstrate the contraceptive efficacy of LPRI-CF113 (drospirenone 4 mg) over 13 treatment cycles, providing data on pregnancy prevention rates that are essential for evaluating its clinical performance as a combined oral contraceptive. The secondary objective is to assess the safety and tolerability of the regimen, including the incidence of adverse events, tolerability profile, and any clinically relevant laboratory changes, thereby informing the overall risk‑benefit assessment.

The trial enrolled sexually active, postmenarcheal and premenopausal women aged 15 to 45 years who were seeking contraception and were willing to rely exclusively on the investigational product for thirteen 28‑day cycles. Participants were required to have a body‑mass index of at least BMI ≥ 18.5 kg/m², regular menstrual cycles (24–35 days) and blood pressure ≤140/90 mmHg measured under standardized conditions. Selection was based on written informed consent, absence of pregnancy, and compliance with lifestyle stipulations such as abstaining from other hormonal contraceptives during the study period. The sponsor did not provide information on the total number of participants.

The study is a prospective, multicentre, open‑label, single‑arm trial evaluating the contraceptive efficacy, safety and tolerability of LPRI‑CF113 (drospirenone 4 mg + 2.8 mg) over thirteen consecutive 28‑day cycles, corresponding to an overall duration of approximately 13 months. Participants undergo an initial screening visit to confirm eligibility criteria, followed by a baseline visit at which the investigational product is dispensed and the first treatment cycle begins. Subsequent study visits occur at the start of each treatment cycle for drug accountability, assessment of adverse events, vital signs, laboratory tests, and gynecological examinations, with additional interim contacts as needed for safety monitoring. The final end‑of‑study visit is scheduled after completion of the thirteenth cycle and includes a comprehensive evaluation of efficacy endpoints, including the primary Pearl Index, and collection of safety data. Participant involvement therefore spans the entire 13‑cycle period, with each cycle lasting 28 days. Early termination may occur in cases of pregnancy, significant adverse events, protocol non‑compliance, withdrawal of consent, or loss to follow‑up.

The investigational product, identified as LPRI‑CF113, is formulated as a drospirenone tablet intended for oral administration. Each tablet contains 4 mg of the active hormonal agent and is to be taken once daily by mouth. The dosing regimen consists of a continuous daily intake throughout each menstrual cycle for a total of 13 consecutive cycles, with no drug‑free interval.

As the study is designed as an open‑label, single‑arm trial, no comparator, placebo, or additional standard‑of‑care therapy is administered. Participants receive only the experimental tablet as the sole contraceptive intervention.

Adherence to the dosing schedule is monitored by requiring participants to complete a daily dosing diary and by performing pill counts at each scheduled study visit. Any missed doses are documented, and compliance rates are calculated based on the number of tablets returned versus the expected consumption.

Efficacy will be evaluated primarily by calculating the Pearl Index in non‑breastfeeding women aged ≤ 35 years at screening over the 13 treatment cycles.

Secondary efficacy assessments include calculation of the Pearl Index in additional subpopulations (all women ≤ 35 years, women aged 15–45 years, women > 35 years), Pearl Index for method failures, Pearl Index corrected for backup contraception and sexual activity, and pregnancy ratios derived from life‑table analysis for evaluable, exposure, and perfect cycles in non‑breastfeeding women ≤ 35 years. Additional secondary measures comprise participant‑reported bleeding and spotting patterns, quality‑of‑life outcomes using the Q‑LES‑Q‑SF, and other safety‑related parameters such as adverse events, laboratory tests, vital signs, and gynecological examinations. All efficacy parameters will be derived from data collected throughout the 13‑cycle treatment period according to the study protocol.