NCT05644444已完成不适用
A Two-arm, Parallel-design, Clinical Investigation to Determine the Effectiveness and Safety of a Water-based Personal Lubricant With a Sensory Action and Silicone-based Personal Lubricant With a Sensory Action for the Relief of Intimate Discomfort Associated With Vaginal Dryness
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Female Sexual Function Index (FSFI) Score Compared to Baseline
研究概览
简要总结
This clinical investigation will look at the effectiveness and safety of two personal lubricants for the relief of intimate discomfort associated with vaginal dryness.
详细描述
This is an open label, two-arm, parallel-design clinical investigation determining the effectiveness and safety of two personal lubricants. This clinical investigation consists of two phases, a Tolerance Phase and a Treatment Phase, whereby a sub-set of subjects will enter the Tolerance Phase followed by the Treatment Phase. The remaining subjects will enter the Treatment Phase only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has provided written informed consent.
- •Subject is aged at least 18 years.
- •Subject in a mutually monogamous heterosexual relationship (≥3 months) who is sexually active, defined as having sexual intercourse at least once a week.
- •Female subject that agrees to have a gynaecological pelvic examination to ensure no significant disease findings and have intact skin and mucous in the test region assessed by the gynaecologist at all the relevant time points.
- •Female subject that agrees to an oral exam by a dermatologist to ensure no significant disease findings and have intact skin and mucous in the test region.
- •Subjects reporting mild to moderate vaginal dryness and dyspareunia during sex (when not using lubricant) in the past 3 months as confirmed on the Verbal Rating Scale (VRS).
- •Pre-menopausal Inclusion Criteria: Female subject of childbearing potential who is willing to use a highly effective method of contraception throughout the clinical investigation.
- •Post-menopausal Inclusion Criteria: Female subject in post-menopausal phase defined as having amenorrhea (absence of menstruation) for at least 12 months.
- •Post-menopausal Inclusion Criteria: Female subject with premature menopause - surgical menopause or physiological menopause within the last 12 months or after having received chemotherapy.
排除标准
- •Subject who has previously experienced an irritant or allergic reaction to any personal lubricant, vaginal moisturiser or female hygiene product or known to have any contact allergen or allergy/hypersensitivity to the test product ingredients.
- •Female subject with history of mucosal intolerance to warming agents.
- •Female subject with continuous or intermittent oral allergy syndrome or burning mouth syndrome of history of thereof.
- •Female subject with urinary, vaginal infection (fungal, bacterial) or sexually transmitted infection which may affect the study outcomes or the safety of the subject.
- •Female subject that has any condition of the oral cavity as determined by the investigator.
- •Male subject has broken skin or wounds in the intimate area.
- •Female subject with a history of skin disorder, which in the opinion of the investigation will affect study outcome.
- •Female subject with autoimmune conditions or any medical conditions which in the opinion of the investigator could compromise the immune function.
- •Female subject who has used any kind of topical histamine and/or topical hormonal based product in the form of an intravaginal cream or moisturiser for local treatment of vaginal dryness in the past 3 months.
- •Female subject using non-medicated, over the counter product, herbal/natural remedies on the vulva, vaginal opening and inside the vagina and is unwilling to stop at least 7 days prior to screening and throughout the duration of clinical investigation.
- •Female subject showing vaginal prolapse and/or other medical conditions that could interfere with the investigation conduct and participation.
- •Female subject who has had surgical cervical excision or vaginal and/or vulvar procedures, including laser and cosmetic procedures to the vulva or vagina in the previous year.
- •Pre-menopausal Exclusion Criteria: Female subject who is pregnant (as confirmed by a positive pregnancy test), breast-feeding or trying to conceive.
- •Post-Menopausal Exclusion Criteria: Female subject that has had previous episodes of vaginal bleeding of unknown origin within the last 6 months.
结局指标
主要结局
Female Sexual Function Index (FSFI) Score Compared to Baseline
时间窗: 4 weeks after baseline
The change in FSFI from the baseline event and at 4-weeks post baseline. The FSFI is a 19-item self-report questionnaire to measure sexual functioning in women. The questionnaire assesses six domains of sexual function (sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain) and provides a total score for sexual function. For individual domain scores, add the scores of the individual questions that comprise the domain and multiply the sum by the domain factor. Add the six domain scores to obtain the total FSFI score. The range of total score is 2.0-36.0. Higher value represents a higher level of sexual function. This measure is the change in total FSFI score between baseline and end of treatment phase (4 weeks).
次要结局
- The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion)(4 weeks after baseline)
- Change From Baseline in the Female Sexual Function Index (FSFI) Individual Domain Scores(4 weeks after baseline)
- Subject Perception of the Personal Lubricants Through Subject Perceived Questions(Initial application (within 24 hours of intercourse) and after 4 weeks)
- The Impression of Change in the Sexual Intimacy (Subjective Opinion)(4 weeks after baseline)
- The Assessment of the Vaginal Epithelial Tolerability (VET)(Baseline, 2 and 24 hours post single application)
- Tolerability as Assessed by Subject Perceived Questions(24 hours post single application)
- Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AEs/ADEs)(10 weeks)
- The Assessment of Overall Tolerance for Each Participant(24 hours post single application)
- The Assessment of Oral Mucosal Tolerance(Baseline, 30 minutes, 2 hours and 24 hours post application)
研究者
研究点 (1)
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