Platelet Rich Plasma (PRP) Peri-urethral and Clitoral Injections for the Treatment of Female Orgasmic Disorder

NCT03189238 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: Pro00021800
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Female Orgasmic Disorder (FOD) is defined as a female sexual disorder with the presence of the following "on all or almost all (75%-100%) occasions of sexual activity":

1. 1.Marked delay in, marked infrequency of, or absence of orgasm
2. 2.Marked reduced intensity of orgasmic sensations.
3. 3.The absence of orgasm must cause personal distress (bother) in order for these symptoms to be considered a disorder. (for example, women who are not very bothered by their lack of orgasm do not have FOD).

Conditions

Female Orgasmic Disorder

Outcome Measures

Primary Outcomes (1)

• ANCOVA

  The ANCOVA will give the investigators adequate power for the proposed sample size (20+20). From the reports of clinicians performing the treatment, the investigators are estimating that the effects to be significant for about 80% of clients. The placebo effect for sexual dysfunction is usually around 40% (see Bradford review, 2013) so that the estimated difference is 40 points which corresponds to a RR (risk ration) = 2, a large effect. A repeated measure ANCOVA with 20 participants per group (2 groups) would have 80% chance of finding a significant difference between groups if the effect size was at least d = .88. An 80% chance is a standard experimental choice that is in line with clinical and medical trials. A Cohen's d above .8 is considered large effect for a treatment study and a d between .5 and .8 is considered medium, thus a sample of 20 + 20 participants is estimated to be adequate to find a large effect as the one expected for this treatment.

  2 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Biological: Peri-urethral and clitoral injections

PRP

ACTIVE COMPARATOR

Biological: Peri-urethral and clitoral injections

Interventions

Peri-urethral and clitoral injections BIOLOGICAL

Peri-urethral and clitoral injections

PRP; Placebo

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \< Female, 25-50 years old. \< Premenopausal \< Signed written informed consent. \< Willingness and ability to comply with the study requirements. \< Subject must meet all of the criteria of FOD as listed in the DSM 5 \< Subjects must score between 0-4 on the Orgasm Domain of the FSFI \< Previously had satisfying orgasms \< Score 11 or greater on the Female Sexual Distress Scale - revised (FSDS-R) \< Are in a continuous, stable sexual relationship with the same partner for at least the 12 months immediately before study enrollment

You may not qualify if:

• \< Who are menopausal \< Who have primary FOD \< Who have pain during sex \< Who are immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease.
• \< Who are not in a stable sexual relationship of at least 12 month duration \< Who suffer from systemic or generalized infections (bacterial, viral or fungal).
• \< Taking psychotropic medications including SSRIs, SNRIs, TCA, bupropion, mood stabilizers, \& treatments for ADD or ADHD including Adderall and similar compounds.
• \< Taking sildenafil, vardenafil, tadalafil \< Taking topical or systemic estrogen or testosterone \< Taking oral contraceptive pills \< Who have been diagnosed with lichen sclerosus, lichen planus, psoriasis, candidiasis, intraepithelial neoplasia, or carcinoma of the vulva.
• \< Who had received an investigational drug within four weeks prior to the study or who intend to use other investigational drugs during the course of this study.
• \< Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
• \< Who have a history of substance abuse or any factor, which limits the subject's ability to cooperate with the study procedures.
• Who are uncooperative, known to miss appointments (according to subjects' records) and are unlikely to follow medical instructions or are not willing to attend regularly scheduled visits.

Sponsors & Collaborators

• Center for Vulvovaginal Disorders: lead

Study Sites (1)

The Center for Vulvovaginal Disorders

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Study Officials

• Andrew T Goldstein, MD

  Director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew T Goldstein, MD

CONTACT

(202) 887-0568; obstetrics@yahoo.com

The Centers for Vulvovaginal Disorders

CONTACT

(202) 887-0568

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a single center study with 40 female patients; twenty placebo and twenty active treatment patients.

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 16, 2017
• Study Start: June 28, 2017
• Primary Completion: May 1, 2019
• Study Completion: July 1, 2019
• Last Updated: June 26, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)