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NCT05461573 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety, and Tolerability of LPRI-CF113 as an Oral Contraceptive in Females
A Phase 3 study, sponsored by Insud Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,542
- Enrollment target
NCT05461573: Completed Phase 3 study, sponsored by Insud Pharma.
NCT05461573 is a Phase 3 study that has completed, run by Insud Pharma. The registered enrollment target is 1,542 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05461573, a Phase 3 study, has completed, sponsored by Insud Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,542 participants
- Enrollment target
Study 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.
Primary Outcome
Calculated by Pearl Index.
Interventions
- DRUG Drospirenone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,542 participants |
| Start Date | 2022-08-02 |
| Est. Completion | 2025-05-27 |
| Phase | Phase 3 |
What the finished NCT05461573 record still lists
NCT05461573 is an interventional study that assigns participants to a tested intervention. Its 1,542 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% higher).
The record links to 0 conditions, and to 1 intervention - of which Drospirenone is the first listed.
NCT05461573 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05461573 about?
NCT05461573 is a clinical study titled "Efficacy, Safety, and Tolerability of LPRI-CF113 as an Oral Contraceptive in Females". 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-C...
What is the current status of trial NCT05461573?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,542 participants. The study started on 2022-08-02. Estimated completion is 2025-05-27.
What interventions are being tested in trial NCT05461573?
The interventions under investigation include: Drospirenone (DRUG).
Who is sponsoring clinical trial NCT05461573?
This trial is sponsored by Insud Pharma, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05461573's enrollment target sits among peer trials
1,542 151st of 2000 higher than 1,850 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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