Sexual DysfunctionPhase 3NCT00981305
Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors
A Phase 3 study testing Lactate-containing vaginal lubricant in people with Sexual Dysfunction and Breast Cancer Survivors, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether lactate-containing vaginal lubricant is effective in the treatment of young breast cancer survivors with sexual dysfunction. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Sexual Dysfunction, Breast Cancer Survivors
- What is being tested?
- Lactate-containing vaginal lubricant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2009to Jul 2015
- Phase
- Phase 3
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- breast cancer survivors over 20 years-old
- premenopausal at the time of diagnosis
- treated with operation and chemotherapy
- newly developed dyspareunia after cancer treatment
Who cannot join
- recent (< 2 months) start or cessation of hormonal treatment (tamoxifen etc.)
- depression or other psychological problems
- active vaginal infection
- evidence of cancer recurrence
- previously use of lactate-containing lubricants
- other chronic diseases which severely disturb the sexual life
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Lactate-containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors: Prospective Randomized Controlled Trial
The purpose of this study is to determine whether lactate-containing vaginal lubricant is effective in the treatment of young breast cancer survivors with sexual dysfunction.
Read the detailed description
Study scheme
- study arm: apply lactate-containing lubricants at the time of sexual intercourse and before sleep at least 3 times per a week for 8 weeks
- control arm: placebo apply
Outcome measures
- Female Sexual function Index (FSFI-20): at 0 wk and at 8 wk
- vaginal maturation index: at 0 wk and 8 wk
- vaginal pH: at 0 wk and 8 wk
- Conditions
- Sexual Dysfunction, Breast Cancer Survivors
- Being tested
- Lactate-containing vaginal lubricant, Placebo vaginal lubricant
- Keywords
- dyspareunia, breast cancer, sexual dysfunction, vaginal lubricant
- Medical subject headings
- Sexual Dysfunction, Physiological, Dyspareunia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactate-containing vaginal lubricantDrug
Also called Clino-san(commercial name in Korea)
vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)
Placebo vaginal lubricantDrug
Also called placebo
vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)
| Study group | Role | What they receive |
|---|---|---|
| Lactate-containing Vaginal Lubricant | Experimental | apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) Receives: Drug: Lactate-containing vaginal lubricant |
| Placebo | Placebo comparator | apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) Receives: Drug: Placebo vaginal lubricant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pain Score of Female Sexual Function Index
The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.
Measured: Baseline and 8 weeks
Secondary outcomes (3)
Change of a Total and Other Five Domains of Female Sexual Function Index Score
The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.
Measured: Baseline and 8 weeks
Change of Vaginal pH
Measured: Baseline and 8 weeks
Change of Vaginal Maturation Index
Vaginal maturation index is a ratio obtained by performing a random cell count of the three major cell types shed from the vaginal squamous epithelium: parabasal, intermediate, and superficial cells. The higher the maturation index, the higher the number of mature cells (those designated superficial and intermediate).
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2015
- Study completionJul 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Collaborating Center, Seoul, Korea
- Responsible party
- Sponsor
- Investigators
- Myung Jae Jeon, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981305
- Sponsor's protocol ID
- SNUH 0905-037-281
- Status last verified
- Oct 2016
- First submitted
- 20 Sep 2009
- Last updated
- 7 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kim YH, Park S, Lee M, Hahn S, Jeon MJ. Effect of a pH-Balanced Vaginal Gel on Dyspareunia and Sexual Function in Breast Cancer Survivors Who Were Premenopausal at Diagnosis: A Randomized Controlled Trial. Obstet Gynecol. 2017 May;129(5):870-876. doi: 10.1097/AOG.0000000000001988.
PubMed 28383379
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lactate-containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors: Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00981305
- Acronym / sponsor ID
- SNUH 0905-037-281
- Conditions
- Sexual Dysfunction, Breast Cancer Survivors
- Keywords
- dyspareunia, breast cancer, sexual dysfunction, vaginal lubricant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Medical Research Collaborating Center, Seoul, Korea
- Study start
- Sep 2009
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Posted 26 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether lactate-containing vaginal lubricant is effective in the treatment of young breast cancer survivors with sexual dysfunction.
Detailed description
Study scheme
- study arm: apply lactate-containing lubricants at the time of sexual intercourse and before sleep at least 3 times per a week for 8 weeks
- control arm: placebo apply
Outcome measures
- Female Sexual function Index (FSFI-20): at 0 wk and at 8 wk
- vaginal maturation index: at 0 wk and 8 wk
- vaginal pH: at 0 wk and 8 wk
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactate-containing Vaginal Lubricant | Experimental | Drug: Lactate-containing vaginal lubricantapply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) |
| Placebo | Placebo comparator | Drug: Placebo vaginal lubricantapply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- breast cancer survivors over 20 years-old
- premenopausal at the time of diagnosis
- treated with operation and chemotherapy
- newly developed dyspareunia after cancer treatment
Key exclusion criteria (6 listed)
- recent (< 2 months) start or cessation of hormonal treatment (tamoxifen etc.)
- depression or other psychological problems
- active vaginal infection
- evidence of cancer recurrence
- previously use of lactate-containing lubricants
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 |
|---|---|---|
| Lactate-containing vaginal lubricantAlso: Clino-san(commercial name in Korea)vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week) | Drug | Lactate-containing Vaginal Lubricant |
| Placebo vaginal lubricantAlso: placebovaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week) | Drug | Placebo |
Primary outcome
Change of Pain Score of Female Sexual Function Index
Time frame: Baseline and 8 weeks
The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.
3 secondary outcomes
Change of a Total and Other Five Domains of Female Sexual Function Index Score
Time frame: Baseline and 8 weeks
Change of Vaginal pH
Time frame: Baseline and 8 weeks
Change of Vaginal Maturation Index
Time frame: Baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28383379Kim YH, Park S, Lee M, Hahn S, Jeon MJ. Effect of a pH-Balanced Vaginal Gel on Dyspareunia and Sexual Function in Breast Cancer Survivors Who Were Premenopausal at Diagnosis: A Randomized Controlled Trial. Obstet Gynecol. 2017 May;129(5):870-876. doi: 10.1097/AOG.0000000000001988.
- Individual participant dataSharing planned: No
Related trials for Sexual Dysfunction
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
PRP for Sexual Function
Female Sexual Dysfunction, Sexual Dysfunction
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
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.
Myung Jae Jeon, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lactate-containing vaginal lubricant in people with Sexual Dysfunction and Breast Cancer Survivors, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 6 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 7 Aug 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2017). 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?
Change of Pain Score of Female Sexual Function Index (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00981305, which also lists 1 linked publication.
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 7 Aug 2017.