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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 is a Phase 3 study that has completed, run by Insud Pharma. The registered enrollment target is 1,542 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05461573
The ClinicalTrials.gov registry entry for NCT05461573 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,542 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Insud Pharma, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Drospirenone is the first listed.
NCT05461573 reports 0 study locations.
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.
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