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NCT04247022
Evaluation of Gynecological Acceptability of a Health Care Product
NA trial testing Health care product (intimate gel) in Atrophic Vaginitis in 74 participants. Completed in 15 July 2021.
15 July 2021
Quick facts
| Lead sponsor | Herbarium Laboratorio Botanico Ltda |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 74 |
| Start date | 9 April 2021 |
| Primary completion | 15 July 2021 |
| Estimated completion | 15 July 2021 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Health care product (intimate gel)
Conditions studied
- Atrophic Vaginitis — all drugs for Atrophic Vaginitis →
- Vaginal Diseases — all drugs for Vaginal Diseases →
Sponsor
Herbarium Laboratorio Botanico Ltda
Who can join
Adults 18 to 59, female only, with Atrophic Vaginitis or Vaginal Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The research will be conducted with a product for use in the intimate region in up to 75 research participants who will use the investigational product for 28 ± 2 days. Will be evaluated and followed up throughout the study by a gynecologist to verify the safety and effectiveness of the product and possible adverse events. The study will evaluate the non-interference of a topical use product on the intimate area, helping to preserve the natural defenses. In addition, the epithelial hydration and pH of the intimate area will be evaluated.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04247022
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Herbarium Laboratorio Botanico Ltda trials
Trials by the same sponsor.
- NCT06723340 — Dermatological Assessment of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Photosensitization · NA · completed
- NCT06353945 — Perceived Effectiveness of the Vaginal Moisturizer Investigational Product Under Normal Conditions of Use. · NA · completed
- NCT05508230 — Evaluation of Cutaneous Acceptability and Perceived Effectiveness of a Nasal Spray (Health Care Products) · NA · completed
- NCT05508243 — Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization of Hyaluronic Nasal Spray · NA · completed
- NCT04250623 — Dermatological Assessment of Photoallergy and Phototoxicity · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04247022 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Herbarium Laboratorio Botanico Ltda
- Last refreshed: 2 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04247022.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing