Clinical management of androgen excess and defect in women

ABSTRACT

Introduction

Hyperandrogenism and hypoandrogenism are complex disorders involving multiple-organ systems. While androgen excess is a well-characterized condition, androgen deficiency still needs diagnostic criteria, as there are no specific cutoffs.

Areas covered

We highlight the most recent findings on the role of androgens in female pathophysiology, investigating clinically relevant conditions of androgen insufficiency or excess throughout a woman’s life, and their possible therapeutic management.

Expert opinion

Combined oral contraceptives (COCs) should be considered as first-line therapy for the management of menstrual irregularity and/or clinical hyperandrogenism in adolescents with a clear diagnosis of polycystic ovary syndrome (PCOS). There are limited evidence-based data regarding specific types or doses of COCs for management of PCOS in women; however, the lowest effective estrogen dose should be considered for treatment. Despite evidence regarding safety, efficacy, and clinical use, testosterone therapy has not been approved for women by most regulatory agencies for treatment of hypoactive sexual desire disorder (HSDD). The long-term safety for treatments with testosterone is still to be evaluated, and this review highlights the need for more research in this area.

KEYWORDS:

• Androgens
• female physiology
• reproduction
• polycystic ovary syndrome
• hypoandrogenism

Article highlights

• Both hyperandrogenism and hypoandrogenism are complex disorders affecting multiple tissues and organs, and in which the list of factors involved in pathophysiology continues to expand.

• COCs should be considered first-line therapy for the management of clinical hyperandrogenism in women diagnosed with PCOS, who lack reproductive desire. There are limited data regarding specific types of progestins, estrogens, or COC combinations for the management of PCOS, but the lowest effective dose of estrogen (20–30 mg EE) should be considered.

• Not all COCs are approved for acne or hirsutism by various regulatory agencies. Notably, the FDA authorized for the treatment of acne the following COCs: NGM/EE triphasic combination; NETA/EE; DRSP/EE.

• The only evidence-based indication for the use of testosterone in women is for the treatment of postmenopausal women who have been diagnosed with HSDD after formal biopsychosocial assessment. There are insufficient data to make any recommendations regarding the use of testosterone in premenopausal women for treatment of sexual function or any other outcome.

• Safety data from RCTs using testosterone in physiologic doses are not available beyond 24 months of treatment. Long-term (beyond 2 years) safety data (with regard to breast cancer and cardiovascular events) are limited to observational trials and are inconclusive. Androgen therapy in women at physiological doses appears to be safe and well tolerated. Adverse side effects are typically associated with supraphysiological doses and excessive duration of treatment.

• Despite this evidence regarding short-term safety, efficacy, and clinical use, testosterone therapy is not approved for women by most regulatory agencies for the treatment of HSDD, including those in Europe and the United States.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.