A Phase 2 interventional study of Oral Testosterone Undecanoate in Hypoactive Sexual Desire Disorder, sponsored by San Diego Sexual Medicine. Not yet recruiting at 1 site in United States. Open to female participants aged 21 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-13.
Sponsored by San Diego Sexual Medicine · Phase 2, Interventional, and Treatment
This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Eligible subjects will receive 50 mg capsules of Kyzatrax® to be taken orally daily over a 3-month period. Multiple blood samples will be taken at baseline and on days 7, 28 and 56 to assess safety and pharmacokinetics of the testosterone. After the informed consent is signed and for up to 14 days after the last dose of study drug, participants will have serial blood samples collected in addition to other routine study procedures (e.g. vital signs measured, adverse events assessed, validated outcome scales completed).
This study is being conducted in an unblinded fashion because the primary endpoint is pharmacokinetic information, and all subjects will receive the same active drug at the same dosage. The primary objectives of this study are to assess the short-term safety and to investigate the pharmacokinetics of serum concentration of total testosterone with daily administration of one (1) 50 mg capsule of testosterone undecanoate (Kyzatrax®) in thirty menopausal women with hypoactive sexual desire disorder (HSDD) and low testosterone. The secondary objective of this study is to assess the efficacy of daily oral administration of one (1) 50 mg capsule of testosterone undecanoate (Kyzatrax®) in thirty menopausal women with HSDD and low testosterone.
The eligibility criterion for testosterone concentration (\< 25 ng/mL [\< 0.87 nmol/L]) is based on the lower limit of the normal testosterone reference range for adult females. The dose of 50 mg was chosen because this is the lowest oral testosterone currently being manufactured and it represents 12.5% of the starting dose of Kyzatrex FDA approved for men (see Attachment 1). Based on the guidelines of the International Society for the Study of Women's Sexual Health, the starting dose of testosterone for peri- and post-menopausal women is approximately 10% of a testosterone product FDA approved for men. In clinical practice, women are typically prescribed testosterone therapy at 10-20% of the dose given to men, depending on individual adsorption and metabolism characteristics.
138 studies on the registry are indexed under Sexual Dysfunctions, Psychological; 10 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 114 interventional studies indexed under Sexual Dysfunctions, Psychological.
Browse Sexual Dysfunctions, Psychological studies →San Diego Sexual Medicine is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 50mg oral testosterone undecanoate daily, have pharmacokinetics assessed and complete validated instruments
Drug: Oral Testosterone Undecanoate
50mg oral testosterone undecanoate daily
Also known as: Kyzatrex
Testosterone
serum concentration of total testosterone to assess safety (adverse events) and pharmacokinetics
Time frame: days 0, 7, 28, 56
Female Sexual Function Index
Female Sexual Function Index to assess changes in each domain and total, total range 2-36, lower the score the more dysfunction therefore worse function
Time frame: Days 0, 28, 56, 84
Plan to share: No
Start is estimated for Jan 2025; primary completion for Dec 2025, 11 months later.
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This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Testosterone undecanoate
Sexual Dysfunctions, Psychological →
San Diego Sexual Medicine