Father Trials: Hormonal Experiments on Prenatal and Postnatal Parenting

• Conditions: There are no medical conditions or diseases under investigation; MedDRA version: 18.1Level: LLTClassification code 10047146Term: VasopressinSystem Organ Class: 10022891 - Investigations; MedDRA version: 18.1Level: PTClassification code 10033329Term: OxytocinSystem Organ Class: 10022891 - Investigations; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2015-003336-12-NL
• Lead Sponsor: niversiteit Leiden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-11
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

In each phase of parenthood (prenatal (child age = -3 months), early postnatal (child age = + 2 months), late postnatal (child age = + 7 months), 40 fathers having their first baby will be recruited to take part in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

Not living in the same house as their partner
Endocrine disorders
Smoking
Alcohol and drug abuse
Use of medication potentially interfering with the endocrine system
MRI contraindications, including metallic foreign objects, neurological disorder and claustrophobia
Psychiatric disorder
Cardiovascular disease
Nose injuries and disorders

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified