NCT00146146

Brief Summary

The purposes of this study are:

  • to determine the role of testosterone versus dihydrotestosterone with respect to the following physiological functions: bone metabolism, body composition, insulin resistance and lipid profile
  • to determine the role of testosterone and dihydrotestosterone versus estradiol with respect to the following physiological functions: bone metabolism, body composition, insulin resistance and lipid profile

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

March 21, 2018

Status Verified

February 1, 2009

Enrollment Period

1 year

First QC Date

September 1, 2005

Last Update Submit

March 19, 2018

Conditions

Transsexualism

Keywords

transsexualismtestosteronedihydrotestosteroneestradiol

Outcome Measures

Primary Outcomes (3)

  • bone metabolism

    baseline and end of the study

  • insulin resistance

    baseline and end of the study

  • lipid profile

    baseline and end of the study

Secondary Outcomes (3)

  • sexual function

    baseline and end of the study

  • mood

    baseline and end of the study

  • pain

    baseline and end of the study

Interventions

testosterone undecanoate aloneDRUG

1000 mg/12 weeks

Also known as: Nebid
testosterone undecanoate plus letrozoleDRUG

TU 1000 mg/12 weeks Letrozole 2.5 mg/day

Also known as: Nebid
testosterone undecanoate plus dutasterideDRUG

TU 1000 mg/12weeks Dutasteride 0.5 mg/day

Also known as: Nebid, Avodart

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy biological females, between 18 and 45 years of age:
  • SR surgery performed
  • Body Mass Index (BMI) between 20 and 29 kg/m²; (body weight in kilograms divided by body height in meters squared)
  • Clinical examination without pathological findings relevant to the study
  • Clinico-chemical laboratory values do not suggest an illness
  • Written Consent Form has been signed
  • High probability of a good compliance and termination of the study

You may not qualify if:

  • Subjects cannot be enrolled in this study if one or more of the following criteria apply:
  • Participation in another clinical trial within the 30 days preceding the first administration
  • Simultaneous participation in another clinical trial
  • Subjects institutionalized or imprisoned by order of the court
  • Subject who compete in sports which use IOC drug monitoring
  • Serious organic or psychic disease suspected from history and/or clinical examination
  • Diseases (especially tumors) that might represent an actual contraindication for testosterone
  • Past or present history of thrombotic or embolic diseases
  • Hypertension requiring therapy (BP 140/90 mmHg)
  • Diabetes mellitus requiring therapy
  • Acute or chronic hepatic diseases
  • Manifest renal diseases with renal dysfunction
  • Severe internal diseases as well as use of any medication to treat such
  • Biochemical and/or hematological laboratory values beyond normal ranges unless the Investigator confirms that the deviations are of no clinical relevance
  • Any indication of chronic use of drugs, alcohol, opiates or recreational drugs
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of Obstetrics and Gynecology - S. Orsola Hospital

Bologna, 40138, Italy

Location

Related Publications (10)

  • Cherrier MM, Matsumoto AM, Amory JK, Ahmed S, Bremner W, Peskind ER, Raskind MA, Johnson M, Craft S. The role of aromatization in testosterone supplementation: effects on cognition in older men. Neurology. 2005 Jan 25;64(2):290-6. doi: 10.1212/01.WNL.0000149639.25136.CA.

    PMID: 15668427BACKGROUND

  • Reddy DS. Testosterone modulation of seizure susceptibility is mediated by neurosteroids 3alpha-androstanediol and 17beta-estradiol. Neuroscience. 2004;129(1):195-207. doi: 10.1016/j.neuroscience.2004.08.002.

    PMID: 15489042BACKGROUND

  • Swaab DF. Sexual differentiation of the human brain: relevance for gender identity, transsexualism and sexual orientation. Gynecol Endocrinol. 2004 Dec;19(6):301-12. doi: 10.1080/09513590400018231.

    PMID: 15724806BACKGROUND

  • Turner A, Chen TC, Barber TW, Malabanan AO, Holick MF, Tangpricha V. Testosterone increases bone mineral density in female-to-male transsexuals: a case series of 15 subjects. Clin Endocrinol (Oxf). 2004 Nov;61(5):560-6. doi: 10.1111/j.1365-2265.2004.02125.x.

    PMID: 15521957BACKGROUND

  • Cherrier MM, Anawalt BD, Herbst KL, Amory JK, Craft S, Matsumoto AM, Bremner WJ. Cognitive effects of short-term manipulation of serum sex steroids in healthy young men. J Clin Endocrinol Metab. 2002 Jul;87(7):3090-6. doi: 10.1210/jcem.87.7.8570.

    PMID: 12107206BACKGROUND

  • Bagatell CJ, Heiman JR, Rivier JE, Bremner WJ. Effects of endogenous testosterone and estradiol on sexual behavior in normal young men. J Clin Endocrinol Metab. 1994 Mar;78(3):711-6. doi: 10.1210/jcem.78.3.8126146.

    PMID: 8126146BACKGROUND

  • Amory JK, Watts NB, Easley KA, Sutton PR, Anawalt BD, Matsumoto AM, Bremner WJ, Tenover JL. Exogenous testosterone or testosterone with finasteride increases bone mineral density in older men with low serum testosterone. J Clin Endocrinol Metab. 2004 Feb;89(2):503-10. doi: 10.1210/jc.2003-031110.

    PMID: 14764753BACKGROUND

  • Levy A, Crown A, Reid R. Endocrine intervention for transsexuals. Clin Endocrinol (Oxf). 2003 Oct;59(4):409-18. doi: 10.1046/j.1365-2265.2003.01821.x. No abstract available.

    PMID: 14510900BACKGROUND

  • Tangpricha V, Ducharme SH, Barber TW, Chipkin SR. Endocrinologic treatment of gender identity disorders. Endocr Pract. 2003 Jan-Feb;9(1):12-21. doi: 10.4158/EP.9.1.12.

    PMID: 12917087BACKGROUND

  • Moore E, Wisniewski A, Dobs A. Endocrine treatment of transsexual people: a review of treatment regimens, outcomes, and adverse effects. J Clin Endocrinol Metab. 2003 Aug;88(8):3467-73. doi: 10.1210/jc.2002-021967.

    PMID: 12915619BACKGROUND

MeSH Terms

Conditions

Transsexualism

Interventions

testosterone undecanoateLetrozoleDutasteride

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAzasteroidsSteroids, HeterocyclicSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Cristina M Meriggiola, MD

    University of Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

May 1, 2005

Primary Completion

May 1, 2006

Study Completion

January 1, 2008

Last Updated

March 21, 2018

Record last verified: 2009-02

Locations

IT(1)