An Open-Label Pilot Study of the Pharmacokinetics and Safety of 50 Mg Oral Testosterone Undecanoate (Kyzatrex) in Menopausal Women with Low Testosterone and Hypoactive Sexual Desire Disorder
San Diego Sexual Medicine
Summary
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).
Description
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 dai…
Eligibility
- Age range
- 21–75 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Participant provides written informed consent and HIPAA authorization before any study procedures are conducted; 2. Participant is female; 3. Participant is aged 30 years or greater; 4. Participant is menopausal either spontaneously (at least 12 months amenorrheic or 6 months amenorrheic and FSH \>40 IU/ml) or 6 weeks after bilateral salpingo-oophorectomy with or without hysterectomy. 5. Participant has a body mass index (BMI) ≤ 34 kg/m2; 6. Participant has a diagnosis of hypoactive sexual desire disorder; 7. At screening, participant has a testosterone concentration \<…
Interventions
- DrugOral Testosterone Undecanoate
50mg oral testosterone undecanoate daily
Location
- San Diego Sexual MedicineSan Diego, California