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NCT03945513 · ClinicalTrials.gov registry record · Phase 3
A Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, and Tolerability of LPRI-424, 13 Cycles
A Phase 3 study of Contraception, sponsored by Insud Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,034
- Enrollment target
- 1
- Study location
NCT03945513: Completed Phase 3 study of Contraception, sponsored by Insud Pharma.
NCT03945513 is a Phase 3 study of Contraception that has completed, run by Insud Pharma. The registered enrollment target is 1,034 participants, above the 440-participant average among 72 other Contraception trials with a reported enrollment target (135% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03945513, a Phase 3 study of Contraception, has completed, sponsored by Insud Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,034 participants
- Enrollment target
- 1
- Study location
Study Summary
The main objective of this trial is to demonstrate the contraceptive efficacy of LPRI424, Additional goals of the trial are to demonstrate the safety and tolerability of LPRI424.
Primary Outcome
Pearl index (PI) from evaluable cycles in non-breastfeeding women aged ≤ 35 years (at the time of trial enrollment)
Conditions Studied
Interventions
- DRUG LPRI424 (dienogest/ethinylestradiol)
Study Locations (1)
Georgia
- Fellows Research Alliance, Inc. - Savannah
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,034 participants |
| Start Date | 2019-12-03 |
| Est. Completion | 2023-09-08 |
| Phase | Phase 3 |
What the finished NCT03945513 record still lists
NCT03945513 is an interventional study that assigns participants to a tested intervention. Its 1,034 participants enrollment target places it among the larger protocols in the corpus, above the 440-participant average among 72 other Contraception trials with a reported enrollment target (135% higher).
The record links to 1 condition, with Contraception appearing as the primary indexed condition, and to 1 intervention - of which LPRI424 (dienogest/ethinylestradiol) is the first listed.
NCT03945513 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT03945513 about?
NCT03945513 is a clinical study titled "A Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, and Tolerability of LPRI-424, 13 Cycles". The main objective of this trial is to demonstrate the contraceptive efficacy of LPRI424, Additional goals of the trial are to demonstrate the safety and tolerability of LPRI424.
What is the current status of trial NCT03945513?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,034 participants. The study started on 2019-12-03. Estimated completion is 2023-09-08.
What conditions does trial NCT03945513 study?
This clinical trial studies the following conditions: Contraception.
What interventions are being tested in trial NCT03945513?
The interventions under investigation include: LPRI424 (dienogest/ethinylestradiol) (DRUG).
Who is sponsoring clinical trial NCT03945513?
This trial is sponsored by Insud Pharma, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03945513 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03945513's enrollment target sits among peer trials
1,034 10th of 72 higher than 63 of 72 other Contraception trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Contraception 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.
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