Testosterone and Its Metabolites in GID (NCT00146146) | Clinical Trial Compass
CompletedPhase 3
Testosterone and Its Metabolites in GID
Italy15 participantsStarted 2005-05
Plain-language 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
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
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 rele…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
bone metabolism
Timeframe: baseline and end of the study
2
insulin resistance
Timeframe: baseline and end of the study
3
lipid profile
Timeframe: baseline and end of the study
Trial details
NCT IDNCT00146146
SponsorUnita Complessa di Ostetricia e Ginecologia