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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 0, 28, 56, 84

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 0, 28, 56, 84

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Testosterone

Secondary outcome measures

Female Sexual Function Index

Side effects data

From 2016 Phase 3 trial • 222 Patients • NCT02722278

Rash

Overdose

Drug Eruption

Rash maculo-papular

Infusion site thrombosis

Feeling jittery

Weight Increased

Blood pressure increased

Headache

Oedema Peripheral

Cellulitis

Sinusitis

Otitis Externa

Dizziness

Disturbance in attention

Nerve Compression

Neck Pain

Rotator Cuff Syndrome

Muscle Strain

Pelvic Facture

Diabetes mellitus

Pollakiuria

Urinary incontinence

Vitreous floaters

Ejaculation disorder

Anaemia

Tooth extraction

Anxiety

Presyncope

Application site pain

Muscle Spasms

Acute Sinusitis

Libido increases

Sunburn

100%

80%

60%

40%

20%

Study treatment Arm

Axiron Testosterone Topical Solution

Oral Testosterone Undecanoate

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

San Diego Sexual MedicineLead Sponsor

3 Previous Clinical Trials

62 Total Patients Enrolled

Irwin Goldstein, MDPrincipal InvestigatorSan Diego Sexual Medicine

6 Previous Clinical Trials

1,112 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research initiative include elderly participants?

"The upper age limit for this trial is 75 years old, while the lower threshold of enrolment is 21."

Answered by AI

What are the eligibility criteria for participation in this experiment?

"This study is seeking 30 individuals with low libido, aged 21 to 75. To be eligible for the trial, these requirements must be met."

Answered by AI

Is Active a safe and viable treatment option for patients?

"Since this is a phase 2 trial, meaning there are some safety data but no efficacy data available yet, our team at Power has assigned an assessment score of 2 to Active's safety."

Answered by AI

Is there still capacity for individuals to join this examination?

"As the details on clinicaltrials.gov indicate, this particular trial is not currently searching for participants anymore; it first appeared online on December 1st 2023 and was last updated October 8th 2023. However, there are still 8 other trials that presently require additional research subjects."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Open-Label Study of 50 mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women With Low Testosterone and HSDD

2023. "An Open-Label Study of 50 mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women With Low Testosterone and HSDD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06082817.

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