Trial reportEBioMedicine2022
Safety assessment scheme for menstrual cups and application for the evaluation of a menstrual cup comprised of medical grade silicone.
Trial report in EBioMedicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.
- Effect of menstrual cups on vaginal health, reproductive tract and urogenital infections: a systematic review and meta-analysis.EBioMedicine · 2026Pooled it
- Characterizing the bacterial surface profiles of menstrual cups and their association with user characteristics and vaginal microbiomes in an adolescent cohort from western Kenya.Gates open research · 2026Trial
- Perspectives on engineering and biomaterials in tampon design: a review of device-tissue interactions and dysmenorrhea risk.Frontiers in bioengineering and biotechnology · 2026Review
- Silicone toothbrushes: A scoping review of an underutilized tool in global oral health.PLOS global public health · 2026Article
- Toxic Shock Syndrome Toxin-1 (TSST-1) inToxins · 2025Review
- Non Clinical Model to Assess the Mechanism of Action of a Combined Hyaluronic Acid, Chondroitin Sulfate and Calcium Chloride: HA+CS+CaClMedical devices (Auckland, N.Z.) · 2024Article
- Cyclical endometrial repair and regeneration: Molecular mechanisms, diseases, and therapeutic interventions.MedComm · 2023Review
- Development ofFrontiers in reproductive health · 2023Article
- The safety assessment of tampons: illustration of a comprehensive approach for four different products.Frontiers in reproductive health · 2023Article
- Editorial: Female urogenital devices used during their lifetime-managing menstruation including pelvic health.Frontiers in reproductive health · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEnsuring menstrual cup safety is paramount, yet a menstrual cup safety assessment scheme is lacking. This paper presents a quadripartite scheme, showing how it can be applied.
methodsThe Tampax Menstrual Cup was evaluated in the safety assessment scheme: (1) Biocompatibility and chemical safety of cup constituents. Extractables were obtained under different use condition; exposure-based risk assessments (EBRA) were conducted for extractables exceeding thresholds of toxicological concern. (2) Physical impact to vaginal mucosa. After physical evaluations, the Tampax Cup and another cup were assessed in a randomised double-blinded, two-product, two-period cross-over clinical trial (65 women, mean age 34.2 years). (3) Impact to vaginal microbiota (in vitro mixed microflora assay and evaluation of vaginal swabs). (4) In vitro growth of Staphylococcus aureus and toxic shock syndrome toxin-1 (TSST-1) production.
findingsBiocompatibility assessments and EBRA of cup constituents showed no safety concerns. In the randomised clinical trial, all potentially product-related adverse effects were mild, vaginal exams were unremarkable, no clinically relevant pH changes occurred, post-void residual urine volume with and without cup were similar, and self-reported measures of comfort along with reports of burning, itching and stinging between cups were comparable. Cup use had no effect on microbial growth in vitro or in the 62 subjects who completed the trial or on in vitro TSST-1 production.
interpretationThe quadripartite safety assessment scheme allows evaluation of menstrual cup safety. The Tampax Cup is safe and well-tolerated upon intended use. As with all feminine hygiene products, post-market safety surveillance confirmed this conclusion.
fundingBy Procter & Gamble.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.