Substance / Medication

Ospemifene

Overview

Active Ingredient
ospemifene
RxNorm CUI
1370971

Indications

OSPHENA is indicated for:

Labeler: Duchesnay USA, Inc.Updated: 2025-02-14T00:00:00.000ZFull label on DailyMed

Contraindications

When this intervention should not be used

OSPHENA is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding. Estrogen-dependent neoplasia. Active DVT, PE, or a history of these conditions. Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions. Hype

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

No related conditions have been mapped yet. Condition-intervention linkages are derived from SNOMED CT relationships and will expand as the knowledge graph grows.

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Research Evidence

Published studies and systematic reviews

Sort:
Ospemifene for the treatment of vulvar and vaginal atrophy: A meta-analysis of randomized trials. Part I: Evaluation of efficacy.
Di Donato Violante, Schiavi Michele Carlo, Iacobelli Valentina et al. · Maturitas · 2019
PMID: 30509753Meta-Analysis
Ospemifene for the treatment of vulvar and vaginal atrophy: A meta-analysis of randomized trials. Part II: Evaluation of tolerability and safety.
Di Donato Violante, Schiavi Michele Carlo, Iacobelli Valentina et al. · Maturitas · 2019
PMID: 30509754Meta-Analysis
Effects of ospemifene on bone in postmenopausal women.
de Villiers T J, Altomare C, Particco M et al. · Climacteric · 2019
PMID: 31294631Meta-Analysis
Endometrial safety of ospemifene: results of the phase 2/3 clinical development program.
Constantine Ginger D, Goldstein Steven R, Archer David F · Menopause · 2015
PMID: 24977459RCTFull text (PMC)
Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy.
Goldstein S R, Bachmann G A, Koninckx P R et al. · Climacteric · 2014
PMID: 23984673RCTFull text (PMC)
Vaginal health, endometrial thickness and changes in bone markers in postmenopausal women after 6 months of treatment with ospemifene in real clinical practice.
Pingarrón Carmen, Lafuente Pilar, Poyo Torcal Silvia et al. · Gynecol Endocrinol · 2022
PMID: 34463164Observational
Long-term use of ospemifene in clinical practice for vulvo-vaginal atrophy: end results at 12 months of follow-up.
Pingarrón Santofímia Carmen, Lafuente González Pilar, Guitiérrez Vélez María Del Carmen et al. · Gynecol Endocrinol · 2022
PMID: 35670533Observational

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Ospemifene (substance)
SNOMED CT
716223004
UMLS CUI
C1313616
RxNorm CUI
1370971
Labeler
Duchesnay USA, Inc.

Clinical Data

This intervention maps to 0 entities in the Ltrl knowledge graph.

0
Conditions
0
Biomarkers
0
Specialists
0
Symptoms

Data is sourced from SNOMED CT, UMLS, and the Ltrl clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.