Generation of Positive Biological Samples to Leuprolide Acetate for Doping Control

The study consists of the generation of biological samples (in urine) positive to leuprorelin acetate for doping control by new developed methods, and establish the analytical parameters that reveal the administration of Leuprorelin acetate in healthy volunteers with these methods.

Study Overview

• Status: Completed
• Conditions: There Are no Conditions Under Study. Healthy Volunteers
• Intervention / Treatment: Drug: LEUPRORELIN ACETATE

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Healthy male volunteers aged from 18 to 45 years.
2. Understanding and accepting the study procedures and signing the informed consent form.
3. A health profile devoid of organic or physiological disorders.
4. The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
5. Body mass index (BMI=weigh/height2) will range between 19 and 25 Kg/m2 and weight between 50 and 100 kg. BMI between 25 and 27 kg/m2 can be included by principal investigator criteria.

Exclusion Criteria:

1. Non compliance of the inclusion criteria.
2. History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance, similar nonapeptides or any excipients.
3. History of allergy or adverse reactions to any medication.
4. Subjects for which the drug involved in the study is counter indicated.
5. History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.
6. History or clinical evidence of alcoholism, drug abuse, or regular use of psychoactive drugs.
7. Have been volunteer in another study with drugs in the last 3 months prior to start this study.
8. Have taken part in studies with blood donation in the last 2 months prior to start this study.
9. Having suffered any organic disease or major surgery in the six months prior to start this study.
10. A prior history of or presence of significant cardiovascular, neurological, haematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease that, in the investigator's opinion, considering the current state of the art, they are clinically significant, are life-threatening for the subjects and could interfere with the product assessment. Especially seizures or a history of epilepsy.
11. Regular use of any drug in the month prior to the study sessions, except for vitamins, herbal remedies or dietary supplements if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. The treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session.
12. Smokers of more than 20 cigarettes per day in the last 3 months prior to start this study.
13. Taking more than 40 g of alcohol per day.
14. Drinking more than 5 cups per day of coffee, tea, coke, stimulants or equivalent, or drinks containing xanthines, in the 3 months prior to start this study.
15. Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
16. Subjects with positive serology for hepatitis B, C or HIV.
17. Subjects with anormal values of testosterone or prostate-specific antigen according to age normal values.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LEUPRORELIN ACETATE	Drug: LEUPRORELIN ACETATE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine concentrations of leuprorelin acetate	Urine samples will be collected in two intervals after the administration of leuprorelin acetate (0-3h; 3-6h) in all experimental study sessions (3 consecutive days).	From the administration to 6 hours post-administration

Collaborators and Investigators

• Sponsor: Parc de Salut Mar

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2016
• Primary Completion (Actual): December 13, 2016
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: September 29, 2016
• First Submitted That Met QC Criteria: September 29, 2016
• First Posted (Estimate): September 30, 2016

Study Record Updates

• Last Update Posted (Actual): October 6, 2017
• Last Update Submitted That Met QC Criteria: October 5, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Leuprolide
• Other Study ID Numbers: IMIMFTCL/LEUPRO; 2016-002719-16 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No