Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03844412) enrolled 209 participants across four groups: a combined treatment group (52 people), a peripheral treatment-only group (52 people), a central treatment-only group (52 people), and a placebo group (53 people). The trial was measuring pain and wellbeing in people with a condition called vestibulodynia — a type of vulvar pain — using several questionnaires and a tampon insertion test. Not everyone who started finished the trial: completion numbers ranged from 34 people in the peripheral treatment group to 47 in the central treatment group. The reported data shows that on the tampon test — where participants rated their pain from 0 (no pain) to 10 (worst possible pain) — scores at the end of the study were between approximately 2.7 and 3.6 across all four groups, down from starting scores that ranged roughly from 3.8 to 4.4. On the McGill Pain Questionnaire (a 0–45 scale where higher means more pain), all four groups reported a decrease in their scores over the course of the trial, with changes ranging from about −4.6 to −5.2 points. On the sexual health measure (scored 0–100, with 50 being the population average), end-of-study scores across groups ranged from roughly 43 to 46, up slightly from starting scores of around 41–42. For physical health and mental health quality-of-life scores, the reported data shows results were only broken down into two subgroups (peripheral and central vestibulodynia), not the four treatment groups — physical health scores were reported as 55.1 and 49.2 respectively, while mental health scores were 36.9 and 36.5, both notably below the general population average of 50. On the cotton-swab pressure pain test, the reported data shows changes in pain scores varied across groups and time points, with figures ranging from around −0.4 to −3.6. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 36269028) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Migraine Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are a woman between 18 and 50 years old
- You are able to read and understand English
- You are willing to give your formal agreement to participate in the study
- You have had pain at the entrance to the vagina during sex and/or pain when inserting a tampon or being touched in that area, lasting at least 3 months in a row
- You scored 3 or higher on a pain test involving tampon insertion
Who may not be able to join:
- You have used certain numbing creams (lidocaine), hormone creams (estradiol), or a combination of both on the vaginal area in the past 3 months
- You have taken nortriptyline or similar antidepressant medications (called TCAs) in the past 3 months
- You have taken pregabalin or gabapentin (nerve pain medications) in the past 3 months
- You currently have an active skin condition affecting the vulva, or a vaginal infection
- You have untreated vaginal dryness/thinning (though you may be able to re-apply after treatment resolves this)
- You have previously had surgery to remove part of the vaginal entrance (vestibulectomy)
- You are pregnant, planning to become pregnant during the study, within the first 6 months after giving birth, currently breastfeeding, or within 3 months of stopping breastfeeding
- You are currently in prison or jail
- You have had cancer within the past year
- You have had chemotherapy or radiation treatment within the past year
- You have an unstable or serious ongoing medical condition, such as kidney problems, heart disease, liver problems, a neurological condition, an autoimmune disease, a significant blood disorder, or a serious breathing condition (confirm with trial site)
- You have a clear inflammatory condition, such as severe obesity (confirm with trial site)
- You are taking medications that suppress the immune system
- You have previously had a bad reaction or intolerance to nortriptyline, lidocaine, or estradiol
- You are currently taking, or have taken in the past 3 months, certain antidepressants (MAOIs, SSRIs, SNRIs, or NDRIs), or have had a heart attack in the past year, have active psychotic or suicidal thoughts, or have a specific type of eye condition called narrow-angle closure glaucoma
- You have a known reason why you cannot use lidocaine or other local anesthetic medications (confirm with trial site)
- You have a known reason why you cannot use topical estrogen therapy (confirm with trial site)
- You have gone through menopause, defined as having had no periods for 12 months in a row, or having had both ovaries surgically removed (having had a hysterectomy alone does not exclude you)
- You have had Botox injections into your pelvic floor muscles in the last 12 months, or nerve block injections in the pelvic area in the last 3 months
- You are currently enrolled in, or planning to join, another clinical trial at the same time as this one
- You are currently receiving pelvic floor physical therapy
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Pain Score During the Tampon Test; Change in Self-reported Pain Via the Short Form- McGill Pain Questionnaire (SF-MPQ); Self-reported Physical Health Via SF-12 Health Survey (SF12v2); Self-reported Mental Health Via SF-12 Health Survey (SF12v2); Sexual Health Via Patient-Reported Outcomes Measurement Information System (PROMIS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.