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NCT02309554 · ClinicalTrials.gov registry record · Phase 1

Postcoital Testing Study of the SILCS Diaphragm Used With 3% N-9 Gel, ContraGel, or No Gel

A Phase 1 study, sponsored by CONRAD.

Completed
Registry status
Phase 1
Development phase
27
Enrollment target

NCT02309554: Completed Phase 1 study, sponsored by CONRAD.

NCT02309554 is a Phase 1 study that has completed, run by CONRAD. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02309554, a Phase 1 study, has completed, sponsored by CONRAD.

COMPLETED
Registry status
Phase 1
Development phase
27 participants
Enrollment target

Study Summary

This post coital test study is a Phase I multi-center, randomized, crossover, non-significant risk device study to be carried out at two clinical sites/centers. The products to be tested are the SILCS diaphragm with 3% Nonoxynol-9 Gel (N-9) (spermicide), the SILCS diaphragm with ContraGel, and the SILCS diaphragm alone. Participants will be randomized to the order of product use, with a goal of 10 participants completing the study.

Primary Outcome

Fewer than 5% progressively motile sperm per high power field is considered indicative of acceptable barrier function. Will be calculated separately for each test cycle.

Interventions

  • OTHER SILCS diaphragm used with ContraGel
  • OTHER SILCS diaphragm used with 3% Nonoxynol-9
  • OTHER SILCS diaphragm

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2014-12
Est. Completion 2016-03
Phase Phase 1
CONRAD

33 total trials

What the finished NCT02309554 record still lists

NCT02309554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).

The record links to 0 conditions, and to 3 interventions - of which SILCS diaphragm used with ContraGel is the first listed.

NCT02309554 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02309554 about?

NCT02309554 is a clinical study titled "Postcoital Testing Study of the SILCS Diaphragm Used With 3% N-9 Gel, ContraGel, or No Gel". This post coital test study is a Phase I multi-center, randomized, crossover, non-significant risk device study to be carried out at two clinical sites/centers. The products to be tested are the SILCS diaphragm with 3% Nonoxynol-9 Gel (N-9) (spermicide), the SILCS diaphragm with ContraGel, and the S...

What is the current status of trial NCT02309554?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2014-12. Estimated completion is 2016-03.

What interventions are being tested in trial NCT02309554?

The interventions under investigation include: SILCS diaphragm used with ContraGel (OTHER), SILCS diaphragm used with 3% Nonoxynol-9 (OTHER), SILCS diaphragm (OTHER).

Who is sponsoring clinical trial NCT02309554?

This trial is sponsored by CONRAD, which has 33 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02309554's enrollment target sits among peer trials

27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT02309554, the US trial registry maintained by the National Library of Medicine. NCT02309554 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.