Prasterone: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: March 22, 2025🚩 Report this page

Prasterone

Active ingredient · 2 therapeutic classes

Sold as INTRAROSA

CA Health CanadaEU EMA

Drug class: Androstan Derivatives
Availability: See label
Routes: Vaginal
Markets covered: 2
Products on record: 2

A14AAAndrostan Derivatives G03XXOther Sex Hormones and Modulators Of The Genital System

Overview

Prasterone is an active pharmaceutical ingredient in the Androstan Derivatives group (A14AA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
CA Canada	Health Canada	1	March 22, 2025
EU European Union	EMA	1	January 15, 2024

CACanada· Health Canada

1 product

Uses

CAOfficial regulatory label· revised March 22, 2025[1]

Intrarosa® (prasterone vaginal ovules) is indicated for:  Treatment of postmenopausal vulvovaginal atrophy. 1 Pediatrics Pediatrics (< 16 years of age): Intrarosa® is indicated only for postmenopausal women. 2 Geriatrics Geriatrics (> 65 years of age): Use as recommended.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised January 15, 2024[2]

Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.

How to take

Sources & citations

[1]Health Canada (DPD) · 02493500 · revised March 22, 2025
[2]European Medicines Agency · EMEA/H/C/004138 · revised January 15, 2024

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[1]

5 mg prasterone). 2 Clinical Trial Adverse Drug Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials, therefore may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The safety data for Intrarosa® were obtained from one single-center and four multicenter, randomized, double blind, placebo-controlled PK/efficacy studies and one uncontrolled, 52-week open-label safety study.
5 mg of prasterone, including 435 women treated daily for one year. 4% for placebo. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings Laboratory Parameters - Hematology, serum chemistry and urinalysis parameters displayed no clinically significant changes from baseline to the final assessment (up to 12 weeks), and values generally remained within the normal adult female ranges.
Serum Prasterone and Related Steroid Levels - Following intravaginal administration of prasterone, serum steroid levels did not increase beyond the normal upper limits for postmenopausal women. Endometrial Biopsies - A total of 882 women had an end-of-study endometrial biopsy in clinical trials ERC-210 (12 weeks), ERC-230 (52 weeks), ERC-231 (12 weeks) and ERC-234 (12 weeks; reduced dosing regimen).
6% (817) of subjects. Cervical Cytology - According to study protocol, participants were to have a normal Pap smear and normal mammography at study entrance. 1%) were reported. The 11 cases of abnormal Pap smear at week 52 included 10 cases of atypical squamous cells of unknown significance (ASCUS) and 1 case of low grade squamous intraepithelial lesion (LSIL).

CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[1]

General Estrogen is a metabolite of prasterone. Use of exogenous estrogen is contraindicated in women with a known history of breast cancer. Intrarosa® has not been studied in women with a history of breast cancer. INTRAROSA® (prasterone vaginal ovules) Page 6 of 17  Women should undergo regular gynecological and breast exams according to current Canadian guidelines.
 Women with vaginal infection should be treated with appropriate antimicrobial therapy before starting treatment with Intrarosa®.  The melting of the hard fat, associated with increased vaginal secretions, may result in vaginal discharge.
1 Pregnant Women Intrarosa® is only indicated in postmenopausal women. There are no data on the use of Intrarosa® in pregnant women. No studies in animals were performed with regard to reproductive toxicity. 2 Breast-feeding Intrarosa® is not indicated during breast-feeding.
It is unknown if the drug is excreted in human milk. 3 Pediatrics Pediatrics (< 16 years of age): Intrarosa® is indicated only in postmenopausal women, therefore safety and effectiveness have not been examined in pediatric patients.
2% of participants in the 52-week open-label clinical trial were over age 65. Use as recommended.

This is not medical advice. Consult a qualified healthcare professional.

5 mg prasterone (one pessary) administered once daily, at bedtime. For the treatment of postmenopausal symptoms, Intrarosa should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be reassessed at least every 6 months and Intrarosa should only be continued as long as the benefit outweighs the risk.
If a dose is forgotten, it should be taken as soon as the patient remembers. However, if the next dose is due in less than 8 hours, the patient should skip the missed pessary. Two pessaries should not be used to make up for a forgotten dose.
Special populations Elderly No dose adjustment is considered necessary in elderly women. Patients with renal and/or hepatic impairment Since Intrarosa acts locally in the vagina, no dose adjustment is needed for postmenopausal women having renal or hepatic impairment or any other systemic anomaly or disease.
Paediatric population There is no relevant use of Intrarosa in female children of any age group for the indication of vulvar and vaginal atrophy due to menopause. 3 Method of administration Vaginal use Intrarosa can be inserted in the vagina with the finger or with an applicator provided within the identified pack.
The pessary should be inserted in the vagina as far as it can comfortably go without force. If inserted with an applicator, the following steps should be followed: 1. The applicator should be activated (by pulling back the plunger) before use.
2. The flat end of the pessary should be placed into the open end of the activated applicator. 3. The applicator should be inserted into the vagina as far as it can comfortably go without force. 4. The plunger of the applicator should be pressed to release the pessary.
5. The applicator should then be withdrawn and disassembled, and the two pieces of the applicator should be rinsed for 30 seconds under running water before wiping with paper towel and reassembled. The applicator should be kept in a clean place until next use.
6. Each applicator should be discarded after one week of usage (two extra applicators are provided).

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised January 15, 2024[2]

Summary of safety profile The most frequently observed adverse reaction was vaginal discharge. This is due to melting of the hard fat used as vehicle, added to the expected increase in vaginal secretions due to treatment. 4). 5 mg pessaries obtained from clinical studies are tabulated in Table 1 below.
5 mg pessaries in clinical studies MedDRA System Organ Class Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) General disorders and administration site conditions Application site discharge - Reproductive system and breast disorders Abnormal Pap smear (mostly ASCUS or LGSIL) Cervical/ uterine polyps Breast mass (benign) Investigations Weight fluctuation - Breast cancer risk • An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined oestrogen-progestagen therapy for more than 5 years.
• Any increased risk in users of oestrogen-only therapy is substantially lower than that seen in users of oestrogen-progestagen combinations. 4). • Results of the largest randomised placebo-controlled study (WHI-study) and largest epidemiological study (MWS) are presented.
2 1-2 (0-3) #Overall risk ratio. The risk ratio is not constant but will increase with increasing duration on use Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately.
4). 56). For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users. In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.
e. deep vein thrombosis or pulmonary embolism. 4). 4). 5 fold increased relative risk of ischaemic stroke. The risk of haemorrhagic stroke is not increased during use of HRT. 4. 6) 3 (1-5) Other adverse reactions have been reported in association with oestrogen/progestagen treatment: – Gall bladder disease.
– Skin and subcutaneous disorders: chloasma, erythema multiforme, erythema nodosum, vascular purpura. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised January 15, 2024[2]

For the treatment of postmenopausal symptoms, Intrarosa should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be reassessed at least every 6 months and Intrarosa should only be continued as long as the benefit outweighs the risk following discussions with their doctor.
Medical examination/follow-up Before initiating Intrarosa, a complete personal and family medical history should be taken. Physical (including pelvic and breast) examination should be guided by this and by the contraindications and special warnings and precautions for use according to the decision of their doctor.
During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised what changes in their breasts should be reported to their doctor or nurse (see ‘Breast cancer’ below).
Investigations, including Pap smears and blood pressure measurements should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual. 4 Conditions which need supervision • If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised.
g. g. liver adenoma) – Diabetes mellitus with or without vascular involvement – Cholelithiasis – Migraine or (severe) headache – Systemic lupus erythematosus. – A history of endometrial hyperplasia (see below) – Epilepsy – Asthma – Otosclerosis Reasons for immediate withdrawal of therapy Therapy should be discontinued in case a contraindication is discovered and in the following situation: – Jaundice or deterioration in liver function – Significant increase in blood pressure – New onset of migraine-type headache – Pregnancy.
Endometrial hyperplasia and carcinoma • Estrogen is a metabolite of prasterone. In women with an intact uterus, the risk of endometrial hyperplasia and carcinoma is increased when exogenous oestrogens are administered for prolonged periods.
No cases of endometrial hyperplasia have been reported in women treated for 52 weeks during the clinical studies. Intrarosa has not been studied in women with endometrial hyperplasia. • For oestrogen products for vaginal application of which the systemic exposure to oestrogen remains within the normal postmenopausal range, it is not recommended to add a progestagen.

This is not medical advice. Consult a qualified healthcare professional.