Vestibülodini: Patofizyolojinin Anlaşılması ve Uygun Tedavilerin Belirlenmesi

Sade dilde özet

Bu çalışma, vestibülodini (vestibulodynia) adı verilen kronik vulvar ağrı durumunda hastalık mekanizmasını anlamayı ve uygun tedavileri belirlemeyi amaçlamaktadır; bu kapsamda lidokain/östradiol içeren krem ile Nortriptyline hapı, plaseboları ile karşılaştırılmaktadır. Çalışmaya, en az 3 aydır süren giriş bölgesi ağrısı olan 18-50 yaş arası kadınlar katılabilmiştir. Çalışma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

Duke University

Müdahale

5% lidocaine/5 mg/ml 0.02% estradiol compound cream, Nortriptyline, Placebo cream, Placebo pill

Başlangıç

04.11.2019

Tahmini bitiş

30.05.2024

Ülkeler

United States

İlgili genler

Merkezler

• Los Angeles, United States
• Chapel Hill, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria

1. Female
2. Age 18-50 years
3. English-literate
4. Willingness to provide informed consent
5. Meeting criteria for diagnosis of VBD based on:

   1. self-report of 3 continuous months of insertional (entryway) dyspareunia, and/or pain to touch/tampon insertion
   2. pain score of ≥ 3 on the tampon insertion test

Exclusion Criteria

1. Use of daily topical lidocaine, or estradiol, or lidocaine/estradiol to the vulvar vestibule within the past three months
2. Use of nortriptyline or other TCA medications within the past three months
3. Use of pregabalin or gabapentin within the past three months
4. Presence of active dermatologic vulvar disease or vaginal infection
5. Untreated atrophic vaginitis (participants may undergo treatment and re-evaluation for enrollment if the condition is resolved)
6. Previous vestibulectomy
7. Pregnant or planning on becoming pregnant during the study period. Within the first six months of the postpartum period. Currently breastfeeding/lactating, or within three months of discontinuing breastfeeding/lactation.
8. Active incarceration
9. Cancer within the past year.
10. Chemotherapy and/or radiation treatment within the past year.
11. Unstable medical condition (e.g., renal impairment, significant hematological disease, cardiovascular disease, hepatic insufficiency, neurological disorder, autoimmune disease, or respiratory illness)
12. Clear inflammatory states (e.g., morbid obesity)
13. Use of immunosuppressant medications
14. History of intolerance to nortriptyline, topical lidocaine, or topical estradiol
15. Contraindications to use of nortriptyline: current use, or use within the past 3 months, of MAOIs, SSRIs, SNRIs, NDRIs; recent (within the past year) myocardial infarction, active psychotic or suicidal thoughts, narrow angle closure glaucoma
16. Contraindications to the use of lidocaine or local anesthetics
17. Contraindications to the use of topical estrogen therapy
18. Post-menopausal, defined as no menses for 12 consecutive months or surgical removal of both ovaries. (Hysterectomy is not an exclusion)
19. Have not had Botox of the pelvic floor muscles in the last 12 months, or pelvic nerve blocks in the last three months.
20. Are not currently enrolled or planning to enroll in another clinical trial during the course of this trial.
21. Are not currently receiving pelvic physical therapy