Female Orgasmic DisorderPhase 2PRPNCT03189238
Platelet Rich Plasma (PRP) Peri-urethral and Clitoral Injections for the Treatment of Female Orgasmic Disorder
A Phase 2 study testing Peri-urethral and clitoral injections in people with Female Orgasmic Disorder, run by Center for Vulvovaginal Disorders at 1 site in United States.
Trial 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. Marked delay in, marked infrequency of, or absence of orgasm 2. Marked reduced intensity of orgasmic sensations. 3. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Female Orgasmic Disorder
- What is being tested?
- Peri-urethral and clitoral injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2017to Jul 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- < 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
Who cannot join
- < 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.
Trial locations and contacts
1 site in 1 country.
The Centers for Vulvovaginal Disorders contact
United States1 site, 1 recruiting
- Recruiting
The Center for Vulvovaginal Disorders
Washington D.C., District of Columbia, 20037
Andrew T Goldstein, MD, 202-887-0568
About this study
Official title: A Double Blind Placebo Controlled Trial of Autologous Platelet Rich Plasma (PRP) Peri-urethral and Clitoral Injections for the Treatment of Female Orgasmic Disorder
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":
- Marked delay in, marked infrequency of, or absence of orgasm
- Marked reduced intensity of orgasmic sensations.
- 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).
Read more
Symptoms must have been present for at least 6 months and are not better explained by a mental disorder or because of a relationship problems or other significant stress in the participant's life and not due to effects of substance abuse or new medications or other medical conditions.
Approximately one in twenty women have FOD and it is the second most frequently reported sexual problem in American women. FOD can either be lifelong (primary) or acquired (secondary).
There are no currently FDA approved treatments or devices for FOD. Therefore, common off-label treatments include psychotherapy/sex therapy, hormone therapy, and medications that increase blood flow to the genitals.
Platelet-rich plasma (PRP) is a platelet concentrate that may help to speed up tissue healing, without serious side effects, in some medical conditions. It has been tried as treatment for diabetic foot ulcers, muscle injury, tendon injury, and in a variety of cosmetic procedures. The only condition for which there are high-quality data and clear demonstration of effectiveness is arthritis of the knee. It is also apparent from the majority of published studies that PRP therapy has minimal risk of scar tissue formation or significant bad side effects.
It has been suggested by many scientists that in some women FOD may be caused by decreased clitoral and genital blood flow secondary to blockage in the small blood vessels going to the clitoris (similar to that seen in erectile dysfunction (ED) in men) and/or diminished nerve conduction (also as seen in ED). PRP activates cells to develop into new tissue-nerves, collagen, and blood vessels. As such, PRP may potentially reverse the changes responsible for FOD. In addition, it has been shown that improved sexual function in women is highly linked with increased blood flow through the clitoris. One component of PRP is known to cause growth of new blood vessels. Therefore, the investigators anticipate PRP injections may potentially improve blood flow through both the clitoris and the tissue around the urethra, thereby improving sexual function and decreasing FOD.
In addition, it has been shown that women who easily achieve orgasm are more likely than women with FOD to have a larger clitoris and a clitoris positioned closer to the vaginal wall. Since PRP has been shown to increase connective tissue, injection of PRP into the clitoris may potentially enlarge the clitoris and may bring the clitoris closer to the vaginal wall, thereby improving orgasm.
There are some reports that physicians using the PRP as an injection near the urethra and clitoris have seen some patients with improvement in FOD after the injections. This is the first study that uses an objective comparative study to find out if this treatment works or not.
- Conditions
- Female Orgasmic Disorder
- Being tested
- Peri-urethral and clitoral injections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri-urethral and clitoral injectionsBiological
Peri-urethral and clitoral injections
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Biological: Peri-urethral and clitoral injections |
| PRP | Active comparator | Not described Receives: Biological: Peri-urethral and clitoral injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start28 Jun 2017 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Orgasmic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a single center study with 40 female patients; twenty placebo and twenty active treatment patients.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Vulvovaginal Disorders
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew T Goldstein, MD, Principal investigator, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189238
- Sponsor's protocol ID
- Pro00021800
- Acronym
- PRP
- Status last verified
- Jun 2017
- First submitted
- 14 Jun 2017
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Placebo Controlled Trial of Autologous Platelet Rich Plasma (PRP) Peri-urethral and Clitoral Injections for the Treatment of Female Orgasmic Disorder
- ClinicalTrials.gov ID
- NCT03189238
- Acronym / sponsor ID
- PRP / Pro00021800
- Conditions
- Female Orgasmic Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Center for Vulvovaginal DisordersUniversity, hospital or other
- Study start
- 28 Jun 2017 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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":
- Marked delay in, marked infrequency of, or absence of orgasm
- Marked reduced intensity of orgasmic sensations.
- 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).
Symptoms must have been present for at least 6 months and are not better explained by a mental disorder or because of a relationship problems or other significant stress in the participant's life and not due to effects of substance abuse or new medications or other medical conditions.
Approximately one in twenty women have FOD and it is the second most frequently reported sexual problem in American women. FOD can either be lifelong (primary) or acquired (secondary).
There are no currently FDA approved treatments or devices for FOD. Therefore, common off-label treatments include psychotherapy/sex therapy, hormone therapy, and medications that increase blood flow to the genitals.
Platelet-rich plasma (PRP) is a platelet concentrate that may help to speed up tissue healing, without serious side effects, in some medical conditions. It has been tried as treatment for diabetic foot ulcers, muscle injury, tendon injury, and in a variety of cosmetic procedures. The only condition for which there are high-quality data and clear demonstration of effectiveness is arthritis of the knee. It is also apparent from the majority of published studies that PRP therapy has minimal risk of scar tissue formation or significant bad side effects.
It has been suggested by many scientists that in some women FOD may be caused by decreased clitoral and genital blood flow secondary to blockage in the small blood vessels going to the clitoris (similar to that seen in erectile dysfunction (ED) in men) and/or diminished nerve conduction (also as seen in ED). PRP activates cells to develop into new tissue-nerves, collagen, and blood vessels. As such, PRP may potentially reverse the changes responsible for FOD. In addition, it has been shown that improved sexual function in women is highly linked with increased blood flow through the clitoris. One component of PRP is known to cause growth of new blood vessels. Therefore, the investigators anticipate PRP injections may potentially improve blood flow through both the clitoris and the tissue around the urethra, thereby improving sexual function and decreasing FOD.
In addition, it has been shown that women who easily achieve orgasm are more likely than women with FOD to have a larger clitoris and a clitoris positioned closer to the vaginal wall. Since PRP has been shown to increase connective tissue, injection of PRP into the clitoris may potentially enlarge the clitoris and may bring the clitoris closer to the vaginal wall, thereby improving orgasm.
There are some reports that physicians using the PRP as an injection near the urethra and clitoris have seen some patients with improvement in FOD after the injections. This is the first study that uses an objective comparative study to find out if this treatment works or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This will be a single center study with 40 female patients; twenty placebo and twenty active treatment patients.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: Peri-urethral and clitoral injections |
| PRP | Active comparator | Biological: Peri-urethral and clitoral injections |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- < 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
Key exclusion criteria (8 listed)
- < 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peri-urethral and clitoral injectionsPeri-urethral and clitoral injections | Biological | PRP, Placebo |
Primary outcome
ANCOVA
Time frame: 2 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The Centers for Vulvovaginal Disorders contact
Andrew T Goldstein, MD principal investigator
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peri-urethral and clitoral injections in people with Female Orgasmic Disorder, run by Center for Vulvovaginal Disorders at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew T Goldstein, MD ((202) 887-0568, obstetrics@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ANCOVA (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.