Is Intrarosa (prasterone) suitable for a 61-year-old female patient with moderate to severe dyspareunia due to vulvar and vaginal atrophy?

Can You Prescribe Intrarosa for a 61-Year-Old Female?

Yes, you can prescribe Intrarosa (prasterone) for a 61-year-old postmenopausal woman with moderate to severe dyspareunia due to vulvar and vaginal atrophy, as it is FDA-approved specifically for this indication and age group. 1, 2

FDA-Approved Indication

• Intravaginal prasterone (Intrarosa) is FDA-approved for treating moderate to severe dyspareunia caused by vulvar and vaginal atrophy in postmenopausal women 2, 3, 4
• The medication is specifically designed for women experiencing pain during sexual intercourse due to estrogen deficiency at menopause 2, 3

Treatment Algorithm Position

Start with non-hormonal options first, then escalate to prasterone if symptoms persist:

• Begin with vaginal moisturizers (3-5 times weekly) combined with water-based lubricants during sexual activity 1
• If symptoms do not improve after 4-6 weeks of consistent non-hormonal therapy, or if symptoms are severe at presentation, escalate to prescription options 1
• Prasterone is recommended as an option for women who have not responded to non-hormonal treatments, particularly those on aromatase inhibitors 1

Clinical Efficacy

• Phase III trials (ERC-231 and ERC-238) demonstrated that prasterone 6.5 mg/day significantly improved vaginal pH, parabasal and superficial cell percentages, and severity of dyspareunia compared to placebo 2
• Benefits were sustained during 52 weeks of continuous treatment in the ERC-230 safety trial 2
• Prasterone improves sexual desire, arousal, pain, and overall sexual function 1, 4

Safety Profile

• Prasterone is generally well tolerated, with the most common adverse event being application site discharge 2
• Unlike other menopausal prescription therapies, intravaginal prasterone does not carry an FDA boxed warning 4
• Serum concentrations of estrogenic and androgenic metabolites remain within normal postmenopausal ranges during treatment 2

Special Considerations and Contraindications

Absolute contraindications include:

• History of hormone-dependent cancers 1
• Undiagnosed abnormal vaginal bleeding 1
• Active or recent pregnancy 1
• Active liver disease 1

For breast cancer survivors:

• Prasterone may be considered for women on aromatase inhibitors who have not responded to non-hormonal options, though limited safety data exists for androgen-based therapy in survivors of hormonally mediated cancers 1
• A thorough discussion of risks and benefits must precede use in this population 1
• Small retrospective studies suggest vaginal estrogens (including DHEA) do not adversely affect breast cancer outcomes 1

Dosing

• The standard dose is intravaginal prasterone 6.5 mg daily 2
• Treatment duration can extend to at least 52 weeks based on safety data 2

Common Pitfalls to Avoid

• Failing to try non-hormonal options first in women without severe symptoms at presentation 1
• Not discussing the option with women who have breast cancer history when they might benefit, as many clinicians avoid all hormonal therapies unnecessarily 1
• Prescribing to women with undiagnosed vaginal bleeding without proper evaluation first 1