NCT03547778 - 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)

Cicinelli E, Didonna T, Ambrosi G, Schönauer LM, Fiore G, Matteo MG
Topical anaesthesia for diagnostic hysteroscopy and endometrial biopsy in postmenopausal women: a randomised placebo-controlled double-blind study. Br J Obstet Gynaecol. 1997 Mar;104(3):316-9.
Urman RD, Punwani N, Bombaugh M, Shapiro FE
Safety considerations for office-based obstetric and gynecologic procedures. Rev Obstet Gynecol. 2013;6(1):e8-e14.

Efficacy of Vaginal Misoprostol For Pain Relief During Office Hysteroscopy and Endometrial Biopsy; A Double Blind Randomized Controlled Trial

Clinical trial NCT03547778 - References