Drug updated on 4/24/2024
| Dosage Form | Tablet (oral; 60 mg) |
| Drug Class | Estrogen agonists/antagonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
- For the treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause.
Summary
- Ospemifene (Osphena) is indicated for the treatment of moderate to severe dyspareunia and vaginal dryness, symptoms of vulvar and vaginal atrophy due to menopause. It has been shown to be as effective as other treatments with a favorable safety profile, including no significant increase in endometrial thickness or risk for endometrial pathology.
- Three studies were reviewed, which provided comprehensive information on Osphena's efficacy, safety, and comparison with other therapies for conditions such as vulvovaginal atrophy (VVA) and dyspareunia due to menopause.
- The first study analyzed 44 controlled trials involving 12,637 participants. It highlighted that there was no significant difference between Osphena's effectiveness compared to other active therapies in treating postmenopausal VVA symptoms.
- A critical subgroup discussed in the second study are breast cancer survivors experiencing VVA symptoms who are using antiestrogen therapy. Among various hormonal treatments reviewed for this population group, ospemifene did not demonstrate an increased risk of breast cancer recurrence.
- This point about its use among breast cancer survivors is particularly important given the balance required between managing VVA symptoms while avoiding elevated estrogen levels that could potentially increase the risk of developing another bout of cancer.
- The third study expanded on available treatment options by reviewing 55 studies related to sexual dysfunction and vaginal atrophy management in postmenopausal women; it emphasized ospemifene amongst these interventions, indicating its viability supported by controlled trials.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Osphena (ospemifene) Prescribing Information. | 2023 | Duchesnay USA, Inc., Bryn Mawr, PA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy, tolerability, and endometrial safety of ospemifene compared with current therapies for the treatment of vulvovaginal atrophy: a systematic literature review and network meta-analysis. | 2023 | Menopause: The Journal of the North American Menopause Society |
| Safety and Serum Estradiol Levels in Hormonal Treatments for Vulvovaginal Atrophy in Breast Cancer Survivors: A Systematic Review and Meta-Analysis. | 2023 | Clinical Breast Cancer |
| Efficacy of Hormonal and Nonhormonal Approaches to Vaginal Atrophy and Sexual Dysfunctions in Postmenopausal Women: A Systematic Review. | 2022 | Federação Brasileira de Ginecologia e Obstetrícia |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| The 2022 hormone therapy position statement of The North American Menopause Society. | 2022 | Menopause |
| Management of postmenopausal vulvovaginal atrophy: recommendations of the International Society for the Study of Vulvovaginal Disease. | 2021 | Gynecological Endocrinology |
| Guideline No. 422b: Menopause and Genitourinary Health. | 2021 | Journal of Obstetrics and Gynaecology Canada |