Research with human participants

Overview of medical research in the Netherlands

A pilot study to investigate the role of androgens in the sexual functioning of women with primary ovary insufficiency (POI).

No registrations found.

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Ethical review
Positive opinion
Status
Pending
Health condition type
-
Study type
Observational non invasive

ID

NL-OMON28298

Source

NTR

Brief title

POI-study

Health condition

POI, POF, sexual dysfunction

Sponsors and support

Primary sponsor :
AMC, Amsterdam
Source(s) of monetary or material Support :
AMC, Amsterdam

Intervention

Outcome measures

Primary outcome

Hormone levels:

1. Estradiol;

2. Total testosterone;

3. Bio-available testosterone;

4. SHBG;

5. Androstenedione;

6. Dehydroepiandrosterone sulfate.



Sexual function:

1. Genital response by VPA;

2. Subjective response by questionnaires, FSFI & FSDS-R.



Implicit association tasks:

1. stIAT;

2. PAT;

3. Dot detection task.

Secondary outcome

The feasibility of these tests in this group, measured by interview.

Background summary

N/A

Study objective

Women with POI have low androgen blood levels which leads to less overall sexual satisfaction, less frequent desire and more pain during sex.

Study design

N/A

Intervention

N/A

Public
AMC, Department of Sexology and Psychosomatic Obstetrics and Gynaecology, H4-205
Sarah Coppes
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
sarah.coppes@student.uva.nl
Scientific
AMC, Department of Sexology and Psychosomatic Obstetrics and Gynaecology, H4-205
Sarah Coppes
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
sarah.coppes@student.uva.nl

Inclusion criteria

1. Participating in the POI-trial in Utrecht;

2. Being treated for POI at the AMC, Amsterdam.

Exclusion criteria

1. Oophorectomy;

2. Severe relationship problems.

Design

Study type :
Observational non invasive
Intervention model
:
Parallel
Allocation :
Non controlled trial
Masking :
Open (masking not used)
Control :
N/A , unknown

Recruitment

NL
Recruitment status
:
Pending
Start date (anticipated) :
Enrollment :
10
Type :
Anticipated

Positive opinion
Date :
Application type :
First submission

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
NTR-new NL2469
NTR-old NTR2585
Other :
ISRCTN ISRCTN wordt niet meer aangevraagd.

Summary results

N/A