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Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration
NCT01161563 · View on ClinicalTrials.gov ↗
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01161563
The ClinicalTrials.gov registry entry for NCT01161563 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Watson Pharmaceuticals, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01161563 reports 16 study locations spanning 12 distinct geographic areas — top geographies include Florida, Indiana, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01161563?
The interventions under investigation include: Leuprolide acetate (DRUG), Triptorelin pamoate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01161563?
This trial is sponsored by Watson Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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