Human Papillomavirus InfectionHPVandFSFINCT03837028
The Human Papilloma Virus Effect on Sexual Life
An observational study of Human Papillomavirus Infection, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Human Papilloma Virus (HPV) is one of the most common causes of sexually transmitted diseases and its link with malignancies is well established, especially with anogenital tract cancers (cervical, vaginal, vulvar, anal cancers). Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- FSFI
- How many people
- 127 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Oct 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women who were attended to our gynecology outpatient clinic due to HPV positivity according to the cervical cancer screening programme were recruited in this study.
Who may be able to join
- women aged between 30 and 50 years
- sexually active women
- women who were first diagnosed with high risk HPV positive (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 69, 82)
Who cannot join
- postmenopausal women (defined as those with at least 12 consecutive months of amenorrhea with no other medical cause and a follicle- stimulating hormone (FSH) level of 40)
- women with chronic disease
- patients with antidepressant usage or patients with psychiatric disorders
- women who did not agree to participate in the study after reading the informed consent form
- women who admitted for follow up due to prior HPV infection
- women with only low-risk HPV (HPV 6, 11) positivity
- women with a sexual abuse history
- women with sexual penetration disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul, 34147
About this study
Official title: The Effect of Human Papilloma Virus Genotype on Women's Sexual Life
Human Papilloma Virus (HPV) is one of the most common causes of sexually transmitted diseases and its link with malignancies is well established, especially with anogenital tract cancers (cervical, vaginal, vulvar, anal cancers). HPV 16 and 18 are the most commonly isolated HPV types in cervical cancer, however not all infections with HPV 16 or 18 progress to cancer. After the HPV test has been used in cervical cancer screening, there have been concerns about whether women carry this virus. Although HPV testing may cause negative emotional responses, adverse emotional responses are related to HPV infection rather than testing. In this respect, there were several studies which evaluated the quality of life and psychological responses of women with positive HPV test results and it is known that positive HPV test results cause additional anxiety, distress and negative emotional responses in women. We hypothesized that the awareness of having a sexually transmitted infection in women with HPV and, therefore, a close follow-up and the need for further investigation such as colposcopy can affect their sexual life. In this study, we aimed to observe the changes in sexual function and anxiety of the HPV positive women with validated objective tools after being informed about their co-test results.
Read the detailed description
The present prospective, observational study was undertaken among women who were attended to our gynecology outpatient clinic due to HPV positivity according to the cervical cancer screening programme. After the ethics approval was obtained from our hospital's local ethics committee, women aged between 30 and 50 years, sexually active, and who were first diagnosed with high risk HPV positive (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 69, 82) were included in the study. Women with HPV positive were given standard information about HPV and HPV testing (co-test) developed by a clinical expert. This information includes; sexually transmitted nature of HPV, its high prevalence in sexually active women, usually transient nature of HPV, the association between high risk and low- risk HPV types and cervical intraepithelial neoplasia (CIN) and cervical cancer, the importance of HPV 16/18 positivity for cervical premalignant and malign lesions. After given the standard information, the patients were informed about their co-test results including HPV genotype, cytology results. The demographic data of the patients such as gravidity, parity,Body Mass Index (BMI), educational status, and marital status were recorded at the time of admission. The routine gynecologic examination was performed to all participants. The BMI was calculated as weight (kg) divided by the square of the height (m2). The patients were divided into four groups according to their HPV genotype and cytology results. The patients were divided into four groups according to their HPV genotype and cytology results. Group 1: HPV 16/18 (+), cytology normal, Group 2: HPV 16/18 (+), cytology abnormal, Group 3: non-16/18 HPV (+), cytology abnormal, Group 4: non-16/18 HPV (+), cytology normal. In our clinic, we manage the patients with abnormal co-test results according to the American Society for Colposcopy and Cervical Pathology guidelines. The patients in group 1, 2, and 3 were referred to colposcopy according to American Society for Colposcopy and Cervical Pathology (ASCCP) guideline and the patients in group 4 were referred to colposcopy according to their symptoms and vaginal examination results such as suspicious cervical observation for cervical intraepithelial neoplasia, postcoital bleeding and all of the participants were informed about the colposcopy procedure. All of the patients called for a follow-up visit two months later and were performed a colposcopy. Sexual function of the patients was assessed at the time of admission and two months later via the self-administered Female Sexual Function Index (FSFI) questionnaire. The anxiety status of the patients has assessed via the Beck Anxiety Inventory (BAI) questionnaire at the time of admission and 2 months later.
Cervical Cancer Screening and management of the results:
According to the national cervical cancer screening program in our country, screening is initiating at the age of 21 and women age <30 are screening with Papanicolaou test alone at intervals of every three years. Women ≥ 30 years have been screening with co-testing (HPV testing and Pap test) every five years. When HPV positivity is detected in the co-test, the HPV genotype is determined and the pap test is evaluated cytologically. While the patients with HPV 16/18 positive (cytology normal or abnormal) and non-HPV 16/18 positive and cytology abnormal referred to a specialist gynecologist for colposcopy, it is recommended that patients who have a non-HPV 16/18 positive and cytology normal should have a co-test after 1 year.
Beck Anxiety Inventory The Beck Anxiety Inventor (BAI) is a brief measure of anxiety with a focus on somatic symptoms of anxiety that was developed as a measure adept at discriminating between anxiety and depression. The BAI is administered via self-report and includes assessment of symptoms such as nervousness, dizziness, inability to relax, etc. The BAI has a total of 21 items. Respondents indicate how much they have been bothered by each symptom over the past week. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). The BAI is used in efforts to obtain a purer measure of anxiety that is relatively independent of depression. The total score is calculated by finding the sum of the 21 items. It is defined as; Score of 0-21 = low anxiety Score of 22-35 = moderate anxiety Score of 36 and above = potentially concerning levels of anxiety Female Sexual Function Index Sexual dysfunction was assessed via the self-administered FSFI which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire (two questions); arousal and lubrication (four questions each); and orgasm, satisfaction, and pain (three questions each). The possible scores are 0-5 for the arousal, lubrication, orgasm, and pain domains; 1-5 for the satisfaction domain; and 1-5 for the desire domain. Domain scores were obtained by summing the scores of the individual items comprising the domain and then multiplying by the following domain factors: 0.6 for desire, 0.3 for arousal and lubrication, and 0.4 for orgasm, satisfaction, and pain. Regarding the individual domains, a score of less than 65% of the maximum achievable score was considered to indicate dysfunction in that domain. Thus, a score of less than 3.9 in each domain was considered to indicate Female sexual disorder (FSD). The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning. The total FSFI score was calculated and categorized as a dichotomous variable using 26.55 as a cutoff for overall Female sexual disorder. Sexual function was further categorized into four groups, as described previously: normal sexual function (total FSFI score ≥26.55), mild Female sexual disorder (total FSFI score 18-26.55), moderate Female sexual disorder (total FSFI score 11-17), and severe Female sexual disorder (total FSFI score ≤10).
We compared the FSFI and BAI scores between the groups and between the time of admission and 2 months later.
- Conditions
- Human Papillomavirus Infection
- Being tested
- FSFI
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSFIOther
Also called Female Sexual Function Index Questionnaire
Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.
| Study group | Role | What they receive |
|---|---|---|
| HPV 16/18 (+), cytology normal | Women who have HPV 16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results.
The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later. Receives: Other: FSFI | |
| HPV 16/18 (+), cytology abnormal | Women who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later. Receives: Other: FSFI | |
| non-16/18 HPV (+), cytology abnormal | Women who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later. Receives: Other: FSFI | |
| non-16/18 HPV (+), cytology normal | Women who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later. Receives: Other: FSFI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Index (FSFI) Score
This is a 19-item questionnaire that covers six domains: desire, arousal, lubrication, and orgasm, satisfaction, and pain. The ranges of the domain scores are as follows: for desire 1.2 - 6.0, for arousal, lubrication, orgasm and pain 0 - 6.0 and for satisfaction 0.8 - 6.0. The higher scores of the six domains indicate better sexual functioning about that domain. The overall FSFI score is obtained by summing the six domain scores. The overall FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning. The change between the initial and second months overall and six domain scores are our first primer outcomes.
Measured: change from initial overall FSFI score at second months.
Secondary outcomes (1)
Beck Anxiety Inventory (BAI) Score
The BAI has a total of 21 items. Respondents indicate how much they have been bothered by each symptom over the past week. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). The total score is calculated by finding the sum of the 21 items. The BAI scores range from 0 to 63 and higher scores are associated with high anxiety levels.
Measured: change from initial BAI score at second months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start1 Jan 2018
- Primary completion1 Jun 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Papillomavirus InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ismail Alay, Principal investigator, University Of Health Sciences Bakirkoy Sadi Konuk Training And Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837028
- Sponsor's protocol ID
- BakirkoyDr.SadiKonuk
- Acronym
- HPVandFSFI
- Status last verified
- Sep 2020
- First submitted
- 8 Feb 2019
- Last updated
- 6 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The researchers in the study have not yet taken a decision on individual participant data (IPD) sharing.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Human Papilloma Virus Genotype on Women's Sexual Life
- ClinicalTrials.gov ID
- NCT03837028
- Acronym / sponsor ID
- HPVandFSFI / BakirkoyDr.SadiKonuk
- Conditions
- Human Papillomavirus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Posted 1 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Human Papilloma Virus (HPV) is one of the most common causes of sexually transmitted diseases and its link with malignancies is well established, especially with anogenital tract cancers (cervical, vaginal, vulvar, anal cancers). HPV 16 and 18 are the most commonly isolated HPV types in cervical cancer, however not all infections with HPV 16 or 18 progress to cancer. After the HPV test has been used in cervical cancer screening, there have been concerns about whether women carry this virus. Although HPV testing may cause negative emotional responses, adverse emotional responses are related to HPV infection rather than testing. In this respect, there were several studies which evaluated the quality of life and psychological responses of women with positive HPV test results and it is known that positive HPV test results cause additional anxiety, distress and negative emotional responses in women. We hypothesized that the awareness of having a sexually transmitted infection in women with HPV and, therefore, a close follow-up and the need for further investigation such as colposcopy can affect their sexual life. In this study, we aimed to observe the changes in sexual function and anxiety of the HPV positive women with validated objective tools after being informed about their co-test results.
Detailed description
The present prospective, observational study was undertaken among women who were attended to our gynecology outpatient clinic due to HPV positivity according to the cervical cancer screening programme. After the ethics approval was obtained from our hospital's local ethics committee, women aged between 30 and 50 years, sexually active, and who were first diagnosed with high risk HPV positive (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 69, 82) were included in the study. Women with HPV positive were given standard information about HPV and HPV testing (co-test) developed by a clinical expert. This information includes; sexually transmitted nature of HPV, its high prevalence in sexually active women, usually transient nature of HPV, the association between high risk and low- risk HPV types and cervical intraepithelial neoplasia (CIN) and cervical cancer, the importance of HPV 16/18 positivity for cervical premalignant and malign lesions. After given the standard information, the patients were informed about their co-test results including HPV genotype, cytology results. The demographic data of the patients such as gravidity, parity,Body Mass Index (BMI), educational status, and marital status were recorded at the time of admission. The routine gynecologic examination was performed to all participants. The BMI was calculated as weight (kg) divided by the square of the height (m2). The patients were divided into four groups according to their HPV genotype and cytology results. The patients were divided into four groups according to their HPV genotype and cytology results. Group 1: HPV 16/18 (+), cytology normal, Group 2: HPV 16/18 (+), cytology abnormal, Group 3: non-16/18 HPV (+), cytology abnormal, Group 4: non-16/18 HPV (+), cytology normal. In our clinic, we manage the patients with abnormal co-test results according to the American Society for Colposcopy and Cervical Pathology guidelines. The patients in group 1, 2, and 3 were referred to colposcopy according to American Society for Colposcopy and Cervical Pathology (ASCCP) guideline and the patients in group 4 were referred to colposcopy according to their symptoms and vaginal examination results such as suspicious cervical observation for cervical intraepithelial neoplasia, postcoital bleeding and all of the participants were informed about the colposcopy procedure. All of the patients called for a follow-up visit two months later and were performed a colposcopy. Sexual function of the patients was assessed at the time of admission and two months later via the self-administered Female Sexual Function Index (FSFI) questionnaire. The anxiety status of the patients has assessed via the Beck Anxiety Inventory (BAI) questionnaire at the time of admission and 2 months later.
Cervical Cancer Screening and management of the results:
According to the national cervical cancer screening program in our country, screening is initiating at the age of 21 and women age <30 are screening with Papanicolaou test alone at intervals of every three years. Women ≥ 30 years have been screening with co-testing (HPV testing and Pap test) every five years. When HPV positivity is detected in the co-test, the HPV genotype is determined and the pap test is evaluated cytologically. While the patients with HPV 16/18 positive (cytology normal or abnormal) and non-HPV 16/18 positive and cytology abnormal referred to a specialist gynecologist for colposcopy, it is recommended that patients who have a non-HPV 16/18 positive and cytology normal should have a co-test after 1 year.
Beck Anxiety Inventory The Beck Anxiety Inventor (BAI) is a brief measure of anxiety with a focus on somatic symptoms of anxiety that was developed as a measure adept at discriminating between anxiety and depression. The BAI is administered via self-report and includes assessment of symptoms such as nervousness, dizziness, inability to relax, etc. The BAI has a total of 21 items. Respondents indicate how much they have been bothered by each symptom over the past week. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). The BAI is used in efforts to obtain a purer measure of anxiety that is relatively independent of depression. The total score is calculated by finding the sum of the 21 items. It is defined as; Score of 0-21 = low anxiety Score of 22-35 = moderate anxiety Score of 36 and above = potentially concerning levels of anxiety Female Sexual Function Index Sexual dysfunction was assessed via the self-administered FSFI which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire (two questions); arousal and lubrication (four questions each); and orgasm, satisfaction, and pain (three questions each). The possible scores are 0-5 for the arousal, lubrication, orgasm, and pain domains; 1-5 for the satisfaction domain; and 1-5 for the desire domain. Domain scores were obtained by summing the scores of the individual items comprising the domain and then multiplying by the following domain factors: 0.6 for desire, 0.3 for arousal and lubrication, and 0.4 for orgasm, satisfaction, and pain. Regarding the individual domains, a score of less than 65% of the maximum achievable score was considered to indicate dysfunction in that domain. Thus, a score of less than 3.9 in each domain was considered to indicate Female sexual disorder (FSD). The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning. The total FSFI score was calculated and categorized as a dichotomous variable using 26.55 as a cutoff for overall Female sexual disorder. Sexual function was further categorized into four groups, as described previously: normal sexual function (total FSFI score ≥26.55), mild Female sexual disorder (total FSFI score 18-26.55), moderate Female sexual disorder (total FSFI score 11-17), and severe Female sexual disorder (total FSFI score ≤10).
We compared the FSFI and BAI scores between the groups and between the time of admission and 2 months later.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HPV 16/18 (+), cytology normal | – | Other: FSFIWomen who have HPV 16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later. |
| HPV 16/18 (+), cytology abnormal | – | Other: FSFIWomen who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later. |
| non-16/18 HPV (+), cytology abnormal | – | Other: FSFIWomen who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later. |
| non-16/18 HPV (+), cytology normal | – | Other: FSFIWomen who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women who were attended to our gynecology outpatient clinic due to HPV positivity according to the cervical cancer screening programme were recruited in this study.
Key inclusion criteria (3 listed)
- women aged between 30 and 50 years
- sexually active women
- women who were first diagnosed with high risk HPV positive (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 69, 82)
Key exclusion criteria (8 listed)
- postmenopausal women (defined as those with at least 12 consecutive months of amenorrhea with no other medical cause and a follicle- stimulating hormone (FSH) level of 40)
- women with chronic disease
- patients with antidepressant usage or patients with psychiatric disorders
- women who did not agree to participate in the study after reading the informed consent form
- women who admitted for follow up due to prior HPV infection
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 |
|---|---|---|
| FSFIAlso: Female Sexual Function Index QuestionnaireSexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning. | Other | HPV 16/18 (+), cytology abnormal, HPV 16/18 (+), cytology normal, non-16/18 HPV (+), cytology abnormal, non-16/18 HPV (+), cytology normal |
Primary outcome
Female Sexual Function Index (FSFI) Score
Time frame: change from initial overall FSFI score at second months.
This is a 19-item questionnaire that covers six domains: desire, arousal, lubrication, and orgasm, satisfaction, and pain. The ranges of the domain scores are as follows: for desire 1.2 - 6.0, for arousal, lubrication, orgasm and pain 0 - 6.0 and for satisfaction 0.8 - 6.0. The higher scores of the six domains indicate better sexual functioning about that domain. The overall FSFI score is obtained by summing the six domain scores. The overall FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning. The change between the initial and second months overall and six domain scores are our first primer outcomes.
1 secondary outcome
Beck Anxiety Inventory (BAI) Score
Time frame: change from initial BAI score at second months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The researchers in the study have not yet taken a decision on individual participant data (IPD) sharing.
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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.
Ismail Alay principal investigator
University Of Health Sciences Bakirkoy Sadi Konuk Training And Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus Infection, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 6 Oct 2020. 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Index (FSFI) Score (time frame: change from initial overall FSFI score at second 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 6 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.