This trial is active, not recruiting.

Conditions kallmann syndrome, congenital hypogonadotropic hypogonadism, idiopathic hypogonadotropic hypogonadism
Sponsor Centre Hospitalier Universitaire Vaudois
Collaborator University of Lausanne
Start date July 2013
End date March 2014
Trial size 148 participants
Trial identifier NCT01914172, 233/13


Kallmann syndrome (KS), also known as congenital hypogonadotropic hypogonadism (CHH), is a rare endocrine disorder that is characterized by failure to undergo puberty combined with infertility. KS/CHH patients face a number of psychosocial burdens related to delays in diagnosis, inadequate access to expert care, and lack of information about the condition. As such, there is some evidence to suggest that KS/CHH patients have unmet health needs. This study aims to identify the needs of patients and understand the issues that must be overcome to achieve improved health and quality of life.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
50-100 patients with KS/CHH will be recruited to complete an online web-based questionnaire (less than 30 minutes to complete)
Focus groups (90-120 minutes in duration) with 6-11 patients

Primary Outcomes

illness perception
time frame: baseline
depression symptoms
time frame: baseline
adherence to treatment
time frame: baseline

Secondary Outcomes

time frame: baseline
Interactions wth healthcare
time frame: baseline

Eligibility Criteria

Male participants from 18 years up to 70 years old.

Inclusion Criteria: - Diagnosed with congenital hypogonadotropic hypogonadism: i.e. Kallmann syndrome or idiopathic hypogonadotropic hypogonadism - Primary language is English/capable of responding to a written questionnaire in English - Consenting to participate in the study Exclusion Criteria: - other diagnosis of hypogonadism: i.e. hypergonadotropic hypogonadism (Klinefelter syndrome), adult onset hypogonadism, etc.

Additional Information

Official title Factors Affecting Health Promoting Behavior in Rare Disease Patients: A Mixed Methods Study of Men With Congenital Hypogonadotropic Hypogonadism (CHH)
Principal investigator Andrew Dwyer, PhD, FNP-BC
Description This study aims to examine the experiences of patients diagnosed with Kallmann syndrome (KS)/congenital hypogonadotropic hypogonadism (CHH). The study includes two parts: - online survey (less than 30 minutes to complete) - focus groups with KS/CHH patients The aim of this project is to better understand what health needs are not presently being met for these patients and to identify targets for improving the care of patients diagnosed with KS/CHH
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire Vaudois.