POPULATION COUNCIL CLINICAL STUDIES
Protocol 173

Name of study: Clinical evaluation of antispermatogenic effects of active immunization against LHRH in normal fertile men

Type of study: Proof of concept

Study phase: Phase 1

Study design: Open-label, prospective study of healthy males ages 35–50 years.

Purpose of the study: To determine safety and pharmacodynamic effects of the immunization in healthy fertile men, including five-year post-immunization safety follow-up of the subjects.

Products to be investigated or studied (including trade and generic names):
Luteinizing hormone-releasing hormone–tetanus toxoid (LHRH-TT) conjugate (in the safety follow-up, the investigator will not administer study medication).

Study start date: 1997

Study end date: Follow-up of all subjects completed at clinic in December 2006

Study sites and associated numbers of subjects at each site:
Instituto Chileno de Medicina Reproductiva, Santiago, Chile (20 subjects)

Criteria for inclusion in study (if applicable): Healthy male volunteers 35 years of age or older.

Note: All clinical studies have appropriate approval from the Institutional Review Boards in the countries in which they are being conducted.