NCT04831099 (N-of-1 DSD) is a Phase 3 clinical trial of Testosterone gel in Disorder of Sex Development, 46,XY, sponsored by Erasmus Medical Center.

Who is sponsoring NCT04831099?

NCT04831099 is sponsored by Erasmus Medical Center.

What drugs are being tested in NCT04831099?

Interventions in NCT04831099: Testosterone gel, Placebo.

What condition does NCT04831099 study?

NCT04831099 studies Disorder of Sex Development, 46,XY.

Is NCT04831099 still recruiting?

NCT04831099 is currently status unknown. Last updated 5 April 2021.

Last reviewed 2021-04-05 · How we verify

NCT04831099: N-of-1 DSD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Testosterone Treatment in a Patient With 17β-hydroxysteroid Dehydrogenase Type 3 Deficiency: an N-of-1 Study

Status unknown Phase 3 Last updated 5 April 2021

What this trial tests

Phase 3 trial testing Testosterone gel in Disorder of Sex Development, 46,XY in 1 participant. Status unknown.

Timeline

1 June 2021

Primary endpoint
26 July 2022

26 July 2022

Quick facts

Lead sponsor	Erasmus Medical Center
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	1
Start date	1 June 2021
Primary completion	26 July 2022
Estimated completion	26 July 2022
Sites	1 location across Netherlands

Drugs / interventions tested

Testosterone gel
Placebo

Conditions studied

Disorder of Sex Development, 46,XY — all drugs for Disorder of Sex Development, 46,XY →

Sponsor

Erasmus Medical Center

Who can join

38 and older, female only, with Disorder of Sex Development, 46,XY. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A 38-year old women with a 46,XY disorder of sex development (DSD) based on a 17β-hydroxysteroid dehydrogenase type 3 deficiency (17β-HSD3) was seen at the department of Internal Medicine-Endocrinology at the Erasmus MC, Rotterdam, the Netherlands. The patient presented with fatigue, concentration problems and feelings of restlessness. In the past, the patient had undergone a gonadectomy at 9 months of age. In a follow-up visit at the outpatient clinic, the patient mentioned that friends with DSD had successfully been treated with testosterone and the patient requested testosterone treatment for her complaints. In the literature, nothing is known about the usefulness of testosterone treatment for women with 17β-HSD3. For other forms of 46,XY DSD like complete androgen insensitivity syndrome (CAIS), limited data are available about testosterone treatment. Two studies have compared the effects of estrogen and testosterone replacement therapy on psychological wellbeing, quality of life (QoL) and sexual function in women with CAIS. The results were not conclusive, as one of them found a positive effect of testosterone replacement therapy on sexual function compared to estrogen, whereas the other study found no differences. In order to evaluate the effect of testosterone treatment independent of a possible placebo effect, the usefulness of testosterone treatment in this individual patient with 17β-HSD3 will be investigated in an N-of-1 trial in order to improve the clinical care for this patient. The primary objective is to determine the efficacy of testosterone treatment for fatigue on an individual level in a patient with 17β-HSD3 as assessed with the Checklist Individual Strength (CIS-20).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Testosterone gel

Trials testing the same drug.

NCT06393634 — Comparing Direct and Indirect Detection Methods of Multiple Routes of Testosterone Administration · EARLY_PHASE1 · completed
NCT06294990 — Klinefelter Syndrome and Testosterone Treatment in Puberty · Phase 4 · recruiting
NCT06253702 — Brain Blood Flow Responses to Stress: Sex Differences · Phase 4 · completed
NCT05586802 — Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome · Phase 3 · recruiting
NCT04166786 — Steroid Profile: Differentiating Testosterone Administration From (Simultaneous) Ethanol Consumption · Phase 1 · completed

Other recruiting trials for Disorder of Sex Development, 46,XY

Currently open trials in the same condition.

NCT05867979 — Search for Structural Variants in Patients With DSD and Inconclusive Molecular Diagnosis · NA · recruiting
NCT06692049 — Gonadal Tissue Cryopreservation for Fertility Preservation in Children with a Disorder of Sex Development · recruiting

Other Erasmus Medical Center trials

Trials by the same sponsor.

NCT07406269 — Clinical Evaluation of AI Decision Support for Early Rehabilitation After Surgery · NA · not yet recruiting
NCT07402109 — CBCT Guided Markerless SBRT for Renal Cell Cancer · NA · recruiting
NCT07383194 — Prediction Models for LDLT Outcomes · not yet recruiting
NCT07426575 — Evaluating the Usability of New Dialysis Bags · not yet recruiting
NCT07329296 — The Regenerative Capacity of the Donor Liver After Living Donor Liver Transplantation: an Ambidirectional Cohort Study · enrolling by invitation

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04831099 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Erasmus Medical Center
Last refreshed: 5 April 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04831099.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing