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Hormone Therapy

Oral Testosterone Undecanoate for Low Libido

Phase 2
Waitlist Available
Led By Irwin Goldstein, MD
Research Sponsored by San Diego Sexual Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is female
Participant is aged 21 years or greater
Must not have
Participant has documented or suspected breast cancer, history of heart attack or stroke
Participant has a hypersensitivity to testosterone, gelatin, glycerin, sorbitol, and titanium dioxide (the constituents of Kyzatrex capsule)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 0, 28, 56, 84
Awards & highlights
No Placebo-Only Group

Summary

This trial will test Kyzatrax®'s safety and effectiveness at increasing testosterone levels over 3 months. Subjects will take a capsule daily and have multiple blood tests.

Who is the study for?
This trial is for menopausal women with low testosterone and HSDD who are in a stable relationship, have a BMI ≤ 35 kg/m2, and experience symptoms of low testosterone. They must be over 21 years old, agree to study procedures, and not have certain health conditions or sensitivities to the medication's ingredients.
What is being tested?
The trial tests Oral Testosterone Undecanoate (Kyztrex) at a single center. Participants take daily capsules for three months with regular blood tests to monitor safety and how the body processes the hormone.
What are the potential side effects?
Potential side effects may include changes in mood or libido, skin reactions at application sites if relevant, hair growth or loss, voice changes, liver function alterations, increased red blood cell count which can lead to complications such as clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am female.
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I am 21 years old or older.
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I have experienced symptoms of low testosterone for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or might have breast cancer and have had a heart attack or stroke.
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I am allergic to ingredients in Kyzatrex capsules.
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I do not need major surgery within 4 weeks before joining or during the study.
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I have not used testosterone treatments other than those provided by the study in the specified time frames.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 0, 28, 56, 84
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 0, 28, 56, 84 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Testosterone
Secondary study objectives
Female Sexual Function Index

Side effects data

From 2016 Phase 3 trial • 222 Patients • NCT02722278
5%
Headache
5%
Haematocrit Increased
4%
Upper respiratory tract infection
3%
Hypertension
3%
High Density Lipoprotein Decreased
2%
Gastrooesophageal reflux disease
2%
Insomnia
2%
Dyspepsia
2%
Oedema Peripheral
2%
Nausea
1%
Presyncope
1%
Hematuria
1%
Anxiety
1%
Osteoarthritis
1%
Atypical pneumonia
1%
Hypoaesthesia
1%
Contusion
1%
Dry mouth
1%
Dizziness
1%
Rash
1%
Cough
1%
Anaemia
1%
Muscle Strain
1%
Myalgia
1%
Eructation
1%
Depression
1%
Pollakiuria
1%
Diarrhoea
1%
Musculoskeletal Pain
1%
Diabetes mellitus
1%
Periumbilical abscess
1%
Abdominal distension
1%
Flushing
1%
Weight Increased
1%
Cellulitis
1%
Sinusitis
1%
Overdose
1%
Small intestinal obstruction
1%
Blood triglycerides increased
1%
Blood pressure increased
1%
Prostatic specific antigen increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Testosterone Undecanoate
Axiron Testosterone Topical Solution

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ActiveExperimental Treatment1 Intervention
Participants will receive 50mg oral testosterone undecanoate daily, have pharmacokinetics assessed and complete validated instruments
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral Testosterone Undecanoate
2016
Completed Phase 3
~250

Find a Location

Who is running the clinical trial?

San Diego Sexual MedicineLead Sponsor
4 Previous Clinical Trials
97 Total Patients Enrolled
Irwin Goldstein, MDPrincipal InvestigatorSan Diego Sexual Medicine
7 Previous Clinical Trials
1,147 Total Patients Enrolled
~20 spots leftby Dec 2025
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