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NCT01161563 · ClinicalTrials.gov registry record · Phase 4

Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration

A Phase 4 study of Prostate Cancer, sponsored by Watson Pharmaceuticals.

Completed
Registry status
Phase 4
Development phase
118
Enrollment target
16
Study locations

NCT01161563: Completed Phase 4 study of Prostate Cancer, sponsored by Watson Pharmaceuticals.

NCT01161563 is a Phase 4 study of Prostate Cancer that has completed, run by Watson Pharmaceuticals. The registered enrollment target is 118 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (81% lower). The trial reports 16 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01161563, a Phase 4 study of Prostate Cancer, has completed, sponsored by Watson Pharmaceuticals.

COMPLETED
Registry status
Phase 4
Development phase
118 participants
Enrollment target
16
Study locations

Study Summary

The purpose of this study is to compare how subjects feel after receiving injections of two different types of GnRH six months apart. One injection is given under the skin of the abdomen, and the other one into the muscle of the buttock or thigh.

Primary Outcome

Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection

Conditions Studied

Interventions

  • DRUG Leuprolide acetate
  • DRUG Triptorelin pamoate

Study Locations (16)

Florida

  • Watson Investigational Site - Daytona Beach
  • Watson Investigational Site - Orange City

Indiana

  • Watson Investigational Site - Carmel
  • Watson Investigational Site - Jeffersonville

New Jersey

  • Watson Investigational Site - Mount Laurel
  • Watson Investigational Site - Voorhees Township

New York

  • Watson Investigational Site - Albany
  • Watson Investigational Site - Syracuse

Alabama

  • Watson Investigational Site - Homewood

Idaho

  • Watson Investigational Site - Coeur d'Alene

Louisiana

  • Watson Investigational Site - Shreveport

Nevada

  • Watson Investigational Site - Las Vegas

Trial Details

FieldValue
Enrollment Target 118 participants
Start Date 2010-07
Est. Completion 2011-04
Phase Phase 4
Watson Pharmaceuticals

28 total trials

What the finished NCT01161563 record still lists

NCT01161563 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (81% lower).

The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Leuprolide acetate is the first listed.

NCT01161563 lists 16 locations in 12 states (Florida, Indiana, New Jersey).

Frequently Asked Questions

What is clinical trial NCT01161563 about?

NCT01161563 is a clinical study titled "Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration". The purpose of this study is to compare how subjects feel after receiving injections of two different types of GnRH six months apart. One injection is given under the skin of the abdomen, and the other one into the muscle of the buttock or thigh.

What is the current status of trial NCT01161563?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 118 participants. The study started on 2010-07. Estimated completion is 2011-04.

What conditions does trial NCT01161563 study?

This clinical trial studies the following conditions: Prostate Cancer.

What interventions are being tested in trial NCT01161563?

The interventions under investigation include: Leuprolide acetate (DRUG), Triptorelin pamoate (DRUG).

Who is sponsoring clinical trial NCT01161563?

This trial is sponsored by Watson Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01161563 being conducted?

This trial has 16 study locations across Alabama, Florida, Idaho, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01161563's enrollment target sits among peer trials

118 311th of 735 higher than 423 of 735 other Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostate Cancer 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 NCT01161563, the US trial registry maintained by the National Library of Medicine. NCT01161563 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.