NCT01352546 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Pacik PT, Cole JB
When Sex Seems Impossible. Stories of Vaginismus & How You Can Achieve Intimacy. Odyne Publishing 2010
Pacik PT, Geletta S
Vaginismus Treatment: Clinical Trials Follow Up 241 Patients. Sex Med. 2017 Jun;5(2):e114-e123. doi: 10.1016/j.esxm.2017.02.002. Epub 2017 Mar 28.
Pacik PT
Botox treatment for vaginismus. Plast Reconstr Surg. 2009 Dec;124(6):455e-6e. doi: 10.1097/PRS.0b013e3181bf7f11.
Pacik PT
Understanding and treating vaginismus: a multimodal approach. Int Urogynecol J. 2014 Dec;25(12):1613-20. doi: 10.1007/s00192-014-2421-y. Epub 2014 Jun 4.
Pacik PT
Vaginismus: review of current concepts and treatment using botox injections, bupivacaine injections, and progressive dilation with the patient under anesthesia. Aesthetic Plast Surg. 2011 Dec;35(6):1160-4. doi: 10.1007/s00266-011-9737-5. Epub 2011 May 10. Review.
Pacik, P
T. (2015), OnabotulinumtoxinA as Part of a Multimodal Program to Treat Vaginismus. Journal of Applied Biobehavioral Research, 20: 25-36. doi:10.1111/jabr.12037

Open Label, Single Center, Pilot Study of the Use of BOTOX Injections, Sensorcaine Injections and Progressive Dilation Under Anesthesia for the Treatment of Primary Vaginismus

Details for clinical trial NCT01352546

Clinical trial NCT01352546 - References