PRP Injections for Postmenopausal Syndrome

Not currently recruiting at 1 trial location
NG
Overseen ByNeha G Gaddam, M.D.
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Medstar Health Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether platelet-rich plasma (PRP) injections can improve sexual function in women with the genitourinary syndrome of menopause (GSM), which often causes vaginal dryness and irritation. PRP, derived from a person's own blood, is already used in various medical treatments. Participants will receive either a PRP injection or a saline (saltwater) injection for comparison. Women diagnosed with GSM, who are sexually active at least once a week, and willing to meet study requirements may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance treatment options for GSM.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used hormonal replacement therapy in the last 3 months.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that PRP (platelet-rich plasma) injections are generally safe for treating symptoms in postmenopausal women. In earlier studies, women who received PRP injections experienced fewer side effects, none of which were serious. No major health problems were linked to the treatment. Another study found that PRP injections effectively improve vaginal health in postmenopausal women. While less information exists on using PRP for sexual issues during menopause, it has been safely used in other areas like bone and joint health and skin care.12345

Why are researchers excited about this trial?

Researchers are excited about platelet-rich plasma (PRP) injections for postmenopausal syndrome because they offer a unique approach compared to standard hormone replacement therapies. PRP is derived from the patient's own blood, minimizing the risk of side effects and allergic reactions associated with synthetic hormones. Unlike traditional treatments that aim to supplement hormone levels, PRP might stimulate the body's natural healing processes and tissue regeneration. This innovative method could provide relief from symptoms with a more personalized and potentially safer treatment option.

What evidence suggests that PRP injections might be an effective treatment for postmenopausal syndrome?

Research shows that PRP (platelet-rich plasma) injections might alleviate symptoms of genitourinary syndrome of menopause (GSM), such as vaginal dryness and irritation. One study found that PRP therapy significantly reduced issues like dryness and itching. Another study demonstrated that PRP is a safe and effective treatment for postmenopausal vulvovaginal atrophy, which involves thinning and inflammation of the vaginal walls, a condition related to GSM. PRP has also improved sexual quality of life for women with GSM symptoms. While researchers continue to gather more data, these studies suggest PRP could be a promising option for managing GSM symptoms. Participants in this trial will receive either PRP injections or a 0.9% saline injection as a sham comparator to evaluate PRP's effectiveness in managing these symptoms.23678

Are You a Good Fit for This Trial?

This trial is for English-speaking women, assigned female at birth, who are at least 18 years old and have been diagnosed with genitourinary syndrome of menopause (GSM). Participants should be sexually active, having had sexual activity weekly in the past month. They must also be willing to follow study requirements.

Inclusion Criteria

English-speaking
I am willing and able to follow the study's requirements.
I have been sexually active at least once a week in the last month.

Exclusion Criteria

I have a pelvic organ prolapse that is visible outside my vaginal opening.
I have not used any hormonal replacement therapy in the last 3 months.
I have a skin condition or infection in my genital area.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PRP injections into the anterior vaginal wall

6 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • PRP Injections
Trial Overview The trial is testing if injections of platelet-rich plasma (PRP) into the vaginal wall can improve sexual function in women with GSM. PRP is a concentration of platelets from your own blood that may stimulate cell growth. The study compares PRP injections against saline (saltwater) injections.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Platelet-rich plasma injectionExperimental Treatment1 Intervention
Group II: 0.9% saline injectionPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials
202
Recruited
187,000+

Citations

Role of Platelet-Rich Plasma in Genitourinary Syndrome ...The combined use of PDT and PRP therapy demonstrated high efficiency in significantly reducing major complaints like dryness and itching and ...
Comparison of topical estrogen and platelet-rich plasma ...Conclusion: PRP injections are a safe and effective minimally invasive monotherapy for postmenopausal VVA and, consequently, vulvovaginal rejuvenation. PRP ...
Platelet-Rich Plasma for Genitourinary Syndrome of...We conducted a prospective, single-arm pilot study of breast cancer survivors (stage 0–III) who reported vaginal dryness with or without dyspareunia.
Evaluation of the efficacy of injectable platelet-rich fibrin in ...This study demonstrated that i-PRF application provided a significant improvement in sexual quality of life among women with GSM symptoms ...
Research trends on platelet-rich plasma in improving ...The summary results of the Meta-Analysis indicated that injection of intraovarian PRP could promote ovarian regeneration and improve the reproductive outcomes ...
Sexual Quality of Life in Postmenopausal WomenThe PRP group exhibited fewer side effects, without systemic symptoms, supporting its favorable safety profile. Conclusions: PRP therapy is a ...
PRP Injections for Genitourinary Syndrome of MenopauseInjection of PRP stimulates cell growth and can has been proven safe and effective for uses in orthopedics, dermatology, and gynecology.
Role of Platelet-Rich Plasma in Genitourinary Syndrome ...A-PRP injection is safe and somewhat effective for female SUI at 1 and 6 months. Potential better outcomes were seen in younger women. The ...
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