Prasterone Vaginal Insert (Intrarosa)
December 30, 2016 3 minutes read
By William Elliott, MD, FACP, and James Chan, PharmD, PhD
Dr. Elliott is Medical Director, Pharmacy, Northern California Kaiser Permanente, and Assistant Clinical Professor of Medicine, University of California, San Francisco. Dr. Chan is Associate Clinical Professor, School of Pharmacy, University of California, San Francisco.
Drs. Elliott and Chan report no financial relationships relevant to this field of study.
The FDA has approved prasterone (dehydroepiandrosterone [DHEA]) as a vaginal insert to treat moderate to severe pain during sexual intercourse in postmenopausal women.
Although available as a dietary supplement for years, prasterone represents the first FDA-approved version of DHEA. Prasterone is marketed as Intrarosa.
INDICATIONS
Prasterone is indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.1
DOSAGE
The recommended dose is one vaginal insert daily at bedtime.1 Each vaginal insert contains 6.5 mg of prasterone.
POTENTIAL ADVANTAGES
Prasterone administered intravaginally does not significantly alter the levels of sex hormones beyond normal post-hormonal values.2
POTENTIAL DISADVANTAGES
Vaginal discharge and abnormal Pap smear findings may occur with prasterone administrations.1
COMMENTS
Prasterone is metabolized intracellularly into active sex steroids, namely estradiol and testosterone. The effectiveness of the vaginal insert was evaluated in two similar randomized, double-blind, placebo-controlled, 12-week trials in postmenopausal women between 40-75 years of age with moderate to severe dyspareunia.1,3
Study participants presented with dyspareunia as their most bothersome symptom of vulvar and vaginal atrophy. In the two studies, 406 subjects were randomized to prasterone and 234 to placebo. They also had ≤ 5% superficial cells on vaginal smear and a vaginal pH > 5. At baseline, the mean dyspareunia severity scores ranged from 2.54-2.63, percent superficial cells, 0.68-1.04, percent parabasal cells, 52-68, and vaginal pH 6.32-6.51. Co-primary endpoints, assessed for improvement at 12 weeks from baseline, were the most bothersome moderate to severe symptoms of dyspareunia, the percent of vaginal superficial cells, the percentage of parabasal cells, and vaginal pH.1
Mean difference in change between prasterone and placebo in severity of dyspareunia were -0.40 (-1.27 vs. -0.87) and -0.35 (-1.42 vs. -1.06) (P = 0.013) respectively in the two studies. Mean difference increase in percent superficial cells were 4.71 (5.6 vs. 0.9) and 8.46 (10.2 vs. 1.75), mean decrease in percent parabasal cells, 45.8 (-47.4 vs. -1.62) and 29.5 (-41.5 vs. -12), and decrease in vaginal pH, -0.83 (-1.04 vs. -0.21) and -0.67 (-0.94 vs. -0.27).
Prasterone showed significant increase over placebo on the Female Sexual Function Index questionnaire in terms of desire, arousal, lubrication, orgasm, satisfaction, and pain at sexual activity.4 An open-label study suggested that the benefit of prasterone is maintained for 52 weeks.5
When male partners were polled, 36% did not feel vaginal dryness of the partner who received prasterone at the end of the 12-week treatment, compared to 7.8% who received placebo.6
CLINICAL IMPLICATIONS
Dyspareunia is a symptom of vulvar and vaginal atrophy due to menopause and associated with the decline in level of estrogen. Circulating DHEA provides the substrate for the production of estrogen and androgens in postmenopausal women. Intravaginal prasterone (DHEA) provides a source of exogenous substrate to increase the level of sex hormones. It provides an option to various formulations of estrogens and oral ospemifene, a selective estrogen receptor modulator, which is FDA-approved for this indication.
Currently, there are no published comparative trials with any of these drugs and prasterone. Cost for prasterone was not available at the time of this review.
REFERENCES
- Intrarosa Prescribing Information. Endoceutics, Inc. November 2016.
- Martel C, Labrie F, Archer DF, et al. Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12 weeks. J Steroid Biochem Mol Biol 2016;159:142-153.
- Labrie F, Archer DF, Koltun W, et al. 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;23:243-256.
- Labrie F, Derogatis L, Archer DF, et al. Effect of intravaginal prasterone on sexual dysfunction in postmenopausal women with vulvovaginal atrophy. J Sex Med 2015;12:2401-2412.
- Labrie F, Archer DF, Bouchard C, et al. Prasterone has parallel beneficial effects on the main symptoms of vulvovaginal atrophy: 52-week open-label study. Maturitas 2015;81:46-56.
- Labrie F, Montesino M, Archer DF, et al. Influence of treatment of vulvovaginal atrophy with intravaginal prasterone on the male partner. Climacteric 2015;18:817-825.
Prasterone is indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
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