An interventional study of Autologous Platelet-Rich Plasma (PRP) Injection and Sterile saline injection in Female Sexual Dysfunction, Sexual Dysfunction and Physiological, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
This randomized, single-blinded, sham-controlled trial evaluates whether a single injection of autologous platelet-rich plasma (PRP) into the distal anterior vaginal wall improves sexual function in women with sexual dysfunction. Sixty participants with a Female Sexual Function Index (FSFI) total score of 26.5 or lower are randomized 1:1 to PRP injection or sterile saline injection. Sexual function, sexual distress, global impression of change, and urinary incontinence symptoms are assessed at baseline, 6 weeks, and 6 months after injection.
Participants complete baseline questionnaires at screening, followed by an in-person injection visit. All participants undergo a 40 mL whole blood draw to preserve blinding. For participants randomized to PRP, the blood is processed using a double-spin centrifugation protocol; for participants randomized to the control arm, the blood sample is discarded. Then 4 cc of PRP or sterile saline is injected with a 25-gauge needle just deep to the vaginal epithelium of the distal anterior vaginal wall, approximately 3 cm from the urethral meatus. Procedural pain is recorded before speculum insertion, during injection, and within 5 minutes after injection. Follow-up assessments at 6 weeks (±7 days) and 6 months (±14 days) may be completed virtually. Randomization uses permuted blocks of variable size (2 and 4), implemented in REDCap. After completing the 6-month follow-up, participants in the saline arm are offered PRP injection at no cost.
385 studies on the registry are indexed under Sexual Dysfunction, Physiological; 72 are open to participants now.
This study's planned enrollment of 60 is below the median of 72 across 263 interventional studies indexed under Sexual Dysfunction, Physiological.
Browse Sexual Dysfunction, Physiological studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single injection of 4-5cc autologous platelet-rich plasma into the distal anterior vaginal wall after blood draw.
Biological: Autologous Platelet-Rich Plasma (PRP) Injection
Participants will receive a single injection of 4-5cc sterile saline into the distal anterior vaginal wall after blood draw (blood sample will be discarded).
Other: Sterile saline injection
Whole blood draw of 40 mL is processed by double-spin centrifugation; 4 cc PRP is injected with a 25-guage needle just deep to the epithelium of the distal anterior vaginal wall, about 3 cm from the urethral meatus, after topical lidocaine.
4-5cc sterile saline injected at the same location, depth, and technique as the PRP arm, following a blood draw.
Change in total score of The Female Sexual Function Index (FSFI)
The Female Sexual Function Index (FSFI) is a 19-item questionnaire to evaluate female sexual function and dysfunction across 6 domains: desire, arousal, lubrication, orgasm, satisfaction, pain. Total scores range from 2.0-36.0; higher scores indicate better sexual function, and scores ≤26.5 indicate sexual dysfunction.
Time frame: Baseline, 6 weeks, and 6 months after injection.
Change in Female Sexual Distress Scale-Revised (FSDS-R) total score
The Female Sexual Distress Scale-Revised (FSDS-R) is a 13-item questionnaire used to measure sexually related personal distress in adult women. Answers are scored on a scale of 0-4, with total scores ranging 0-52; higher scores indicate greater sexual distress, and scores ≥11 indicate clinically significant distress.
Time frame: Baseline, 6 weeks, and 6 months after injection.
Patient Global Impression of Improvement (PGI-I)
Patient Global Impression of improvement (PGI-I) is a single item scale assessing a patient's perception of change in their condition following treatment. The assessment is scored 1-7. Lower scores mean greater improvement. Scores of 1-3 are defined as a response.
Time frame: 6 weeks and 6 months after injection.
Change in FSFI domain scores
The Female Sexual Function Index (FSFI) is a 19-item questionnaire to evaluate female sexual function and dysfunction across 6 domains: desire, arousal, lubrication, orgasm, satisfaction, pain. Domains are scored 0 (or 1.2) to 6.0. Total scores range from 2.0-36.0. Higher scores indicate better sexual function.
Time frame: Baseline, 6 weeks, and 6 months from injection visit.
Stress Urinary Incontinence Symptom Frequency
Among participants reporting incontinence: leakage frequency with activity is scored on a scale of 0 (never) to 5 (several times per day). Higher scores indicate more frequent leakage.
Time frame: Baseline, 6 weeks, and 6 months from injection visit.
Visual Analogue Scale (VAS)
The Visual Analogue Scale (VAS) is a single item questionnaire used to measure pain intensity. The assessment is scored on a scale of 0-10; higher scores indicate worse pain.
Time frame: Day of injection - before speculum insertion, during injection, and within 5 minutes after injection
Number of participants with adverse events.
Number of participants with treatment related adverse events post injection.
Time frame: From injection through 6 months.
Plan to share: No — Individual participant data contain sensitive sexual-health information, and the informed consent does not provide for sharing individual-level data. Results will be shared in aggregate through publication.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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