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

NCT06082817 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: SDSM-2023-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hypoactive Sexual Desire Disorder

Outcome Measures

Primary Outcomes (1)

• Testosterone

  serum concentration of total testosterone to assess safety (adverse events) and pharmacokinetics

  days 0, 7, 28, 56

Secondary Outcomes (1)

• Female Sexual Function Index

  Days 0, 28, 56, 84

Study Arms (1)

Active

EXPERIMENTAL

Participants will receive 50mg oral testosterone undecanoate daily, have pharmacokinetics assessed and complete validated instruments

Drug: Oral Testosterone Undecanoate

Interventions

Oral Testosterone Undecanoate DRUG

50mg oral testosterone undecanoate daily

Also known as: Kyzatrex

Active

Eligibility Criteria

• Age: 21 Years - 75 Years
• Gender Eligibility Details: Cis-gender female identifying as a female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant provides written informed consent and HIPAA authorization before any study procedures are conducted;
• Participant is female;
• Participant is aged 30 years or greater;
• 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.
• Participant has a body mass index (BMI) ≤ 34 kg/m2;
• Participant has a diagnosis of hypoactive sexual desire disorder;
• At screening, participant has a testosterone concentration \<30 ng/dL;
• Participant has a normal PAP smear within 6 months of first administration of study drug if participant has a cervix;
• Participant has a normal mammogram within 6 months of first administration of study drug;
• Participant agrees to comply with the study procedures and visits.

You may not qualify if:

• Participant has a hypersensitivity to testosterone, gelatin, glycerin, sorbitol, or titanium dioxide (the constituents of Kyzatrex capsule);
• Participant has received intramuscular testosterone injections, oral or transdermal testosterone within 4 weeks, or subcutaneous testosterone pellet within 6 months prior to the screening visit, or receives any form of testosterone other than study drug during this trial;
• Participant has documented or suspected breast cancer, history of heart attack or stroke;
• Participant has a clinically significant history of disease which could alter absorption, distribution, metabolism, or elimination, such as hepatic, renal, hematologic, gastrointestinal, respiratory, endocrine, or neurological disease;
• Participant has an EKG with an abnormality of clinical significance;
• Participant has an abnormal PAP smear if she has a cervix;
• Participant has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;
• Participant requires major surgery within 4 weeks before signing consent or at any time during the study;
• Participant requires a treatment with any medication listed in Appendix 1 at any time between 30 days before study drug is started or any time until the end of the study;
• Participant has a history of substance abuse within 12 months prior to signing consent;
• Participant has received an investigational drug within 30 days prior to signing consent;
• Participant has any condition or exhibits behavior that indicates to the Principal Investigator that the participant is unlikely to be compliant with study procedures and visits.

Sponsors & Collaborators

• San Diego Sexual Medicine: lead

Study Sites (1)

San Diego Sexual Medicine

San Diego, California, 92120, United States

Location

Related Publications (6)

• Clayton AH, Goldstein I, Kim NN, Althof SE, Faubion SS, Faught BM, Parish SJ, Simon JA, Vignozzi L, Christiansen K, Davis SR, Freedman MA, Kingsberg SA, Kirana PS, Larkin L, McCabe M, Sadovsky R. The International Society for the Study of Women's Sexual Health Process of Care for Management of Hypoactive Sexual Desire Disorder in Women. Mayo Clin Proc. 2018 Apr;93(4):467-487. doi: 10.1016/j.mayocp.2017.11.002. Epub 2018 Mar 12.

  PMID: 29545008 BACKGROUND

• Parish SJ, Simon JA, Davis SR, Giraldi A, Goldstein I, Goldstein SW, Kim NN, Kingsberg SA, Morgentaler A, Nappi RE, Park K, Stuenkel CA, Traish AM, Vignozzi L. International Society for the Study of Women's Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women. J Sex Med. 2021 May;18(5):849-867. doi: 10.1016/j.jsxm.2020.10.009. Epub 2021 Apr 1.

  PMID: 33814355 BACKGROUND

• Bachmann G, Bancroft J, Braunstein G, Burger H, Davis S, Dennerstein L, Goldstein I, Guay A, Leiblum S, Lobo R, Notelovitz M, Rosen R, Sarrel P, Sherwin B, Simon J, Simpson E, Shifren J, Spark R, Traish A; Princeton. Female androgen insufficiency: the Princeton consensus statement on definition, classification, and assessment. Fertil Steril. 2002 Apr;77(4):660-5. doi: 10.1016/s0015-0282(02)02969-2.

  PMID: 11937111 BACKGROUND

• Davis SR, Wahlin-Jacobsen S. Testosterone in women--the clinical significance. Lancet Diabetes Endocrinol. 2015 Dec;3(12):980-92. doi: 10.1016/S2213-8587(15)00284-3. Epub 2015 Sep 7.

  PMID: 26358173 BACKGROUND

• White WB, Bernstein JS, Rittmaster R, Dhingra O. Effects of the oral testosterone undecanoate Kyzatrex on ambulatory blood pressure in hypogonadal men. J Clin Hypertens (Greenwich). 2021 Jul;23(7):1420-1430. doi: 10.1111/jch.14297. Epub 2021 Jun 11.

  PMID: 34114726 BACKGROUND

• Asghar AA, Hashmi MR, Ahmed R, Khabir Y. Kyzatrex - Oral testosterone replacement therapy. Ann Med Surg (Lond). 2022 Sep 11;82:104625. doi: 10.1016/j.amsu.2022.104625. eCollection 2022 Oct. No abstract available.

  PMID: 36268410 BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Irwin Goldstein, MD

  San Diego Sexual Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sue W Goldstein, BA

CONTACT

619-265-8865; suewgoldstein@gmail.com

Claudia Gardner, BA

CONTACT

619-265-8865; cgardner@sdsm.info

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label 50mg daily dosing with pharmacokinetics assessed by multiple blood draws

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 13, 2023
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)