STEPS

New Drug Reviews

Prasterone (Intrarosa) for Dyspareunia

 

Am Fam Physician. 2019 Jan 15;99(2):121-122.

Prasterone (Intrarosa) is an intravaginal product used to treat moderate to severe dyspareunia due to vulvar and vaginal atrophy caused by menopause.1 The mechanism of action of intravaginal prasterone is not known, but it may involve local metabolism to estrogens and androgens.2,3

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DrugDosageDose formCost*

Prasterone vaginal insert (Intrarosa)

One 6.5-mg vaginal insert, using provided applicator once daily at bedtime

6.5-mg vaginal insert

$210


*—Estimated retail price of one month of treatment based on information obtained at https://www.goodrx.com (accessed October 24, 2018).

DrugDosageDose formCost*

Prasterone vaginal insert (Intrarosa)

One 6.5-mg vaginal insert, using provided applicator once daily at bedtime

6.5-mg vaginal insert

$210


*—Estimated retail price of one month of treatment based on information obtained at https://www.goodrx.com (accessed October 24, 2018).

Safety

In a 52-week noncomparative clinical trial of 530 postmenopausal women with previously normal Papanicolaou (Pap) test results, 2.1% who used intravaginal prasterone developed abnormal Pap tests at study completion. Most of these abnormalities consisted of atypical squamous cells of undetermined significance (ASCUS).1,3 These results are similar to the incidence of ASCUS in postmenopausal patients outside of this trial, but follow-up data on Pap tests in this population have not been reported. Prasterone has not been shown to increase serum steroid concentrations, nor has it been linked to the development of endometrial hyperplasia or endometrial cancer.4,5 Prasterone has not been studied in patients with a history of breast cancer, renal impairment, or hepatic impairment.1,3 It is contraindicated in women with undiagnosed abnormal genital bleeding.1 Prasterone should be prescribed only for use in postmenopausal women. It has not been evaluated for use in pregnant or lactating women.1,3

Tolerability

Prasterone is generally well tolerated. The most common adverse effect is vaginal discharge, occurring in 2.7% of women vs. 1.3% of control patients (number needed to treat to harm = 72), although the discontinuation rate because of adverse effects is similar to that with placebo.3,4

Effectiveness

Effectiveness has been evaluated in two clinical trials of 716 women with vaginal dryness and moderate to severe dyspareunia who reported avoiding or refraining from sexual activity because of pain (a score of 2 or 3 on a scale of 0 to 3, in which 3 is the worst pain). Using the prasterone 6.5-mg vaginal insert each evening will improve dyspareunia symptoms by 0.36 to 0.40 severity points more than an oil-based placebo at 12 weeks (P < .05 vs. placebo). The clinical significance of this difference is unclear.3,4 Individual symptoms such as vaginal

Author disclosure: No relevant financial affiliations.

Address correspondence to Rebecca Hayes, MD, at Rebecca.Hayes@atriumhealth.org. Reprints are not available from the authors.

References

show all references

1. DailyMed. Drug label information: Intrarosa—prasterone insert. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df731acd-7276-4fef-b037-bc7f30c112cb. Accessed April 6, 2018....

2. Archer DF, Labrie F, Bouchard C, et al.; VVA Prasterone Group. Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone). Menopause. 2015;22(9):950–963.

3. U.S. Food and Drug Administration. Center for Drug Evaluation and Research. Application number: 208470Orig1s000. Summary review. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000SumR.pdf. Accessed April 6, 2018.

4. Labrie F, Archer DF, Koltun W, et al.; VVA Prasterone Research Group. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Menopause. 2016;23(3):243–256.

5. Martel C, Labrie F, Archer DF, et al.; other participating members of the Prasterone Clinical Research Group. Serum steroid concentrations remain within normal post-menopausal values in women receiving daily 6.5 mg intravaginal prasterone for 12 weeks. J Steroid Biochem Mol Biol. 2016;159:142–153.

6. Archer DF, Labrie F, Montesino M, Martel C. Comparison of intravaginal 6.5 mg (0.50%) prasterone, 0.3 mg conjugated estrogens and 10 μg estradiol on symptoms of vulvovaginal atrophy. J Steroid Biochem Mol Biol. 2017;174:1–8.

7. Labrie F, Archer D, Bouchard C, et al. Lack of influence of dyspareunia on the beneficial effect of intravaginal prasterone (dehydroepiandrosterone, DHEA) on sexual dysfunction in postmenopausal women. J Sex Med. 2014;11(7):1766–1785.

8. Labrie F, Derogatis L, Archer DF, et al.; Members of the VVA Prasterone Research Group. Effect of intravaginal prasterone on sexual dysfunction in postmenopausal women with vulvovaginal atrophy. J Sex Med. 2015;12(12):2401–2412.

9. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10(4):407–415.

10. Baulieu EE, Thomas G, Legrain S, et al. Dehydroepiandrosterone (DHEA), DHEA sulfate, and aging: contribution of the DHEAge Study to a sociobiomedical issue. Proc Natl Acad Sci U S A. 2000;97(8):4279–4284.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, Contributing Editor.

A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.

 

 

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