NCT02472184 - 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)

American College of Obstetricians and Gynecologists
Technology assessment No. 7: Hysteroscopy. Obstet Gynecol. 2011 Jun;117(6):1486-91. doi: 10.1097/AOG.0b013e3182238c7d.
Clark TJ, Voit D, Gupta JK, Hyde C, Song F, Khan KS
Accuracy of hysteroscopy in the diagnosis of endometrial cancer and hyperplasia: a systematic quantitative review. JAMA. 2002 Oct 2;288(13):1610-21. Review.
Committee on Practice Bulletins—Gynecology
Practice bulletin no. 128: diagnosis of abnormal uterine bleeding in reproductive-aged women. Obstet Gynecol. 2012 Jul;120(1):197-206. doi: 10.1097/AOG.0b013e318262e320.
Ghaly S, de Abreu Lourenco R, Abbott JA
Audit of endometrial biopsy at outpatient hysteroscopy. Aust N Z J Obstet Gynaecol. 2008 Apr;48(2):202-6. doi: 10.1111/j.1479-828X.2008.00834.x.
Kelekci S, Kaya E, Alan M, Alan Y, Bilge U, Mollamahmutoglu L
Comparison of transvaginal sonography, saline infusion sonography, and office hysteroscopy in reproductive-aged women with or without abnormal uterine bleeding. Fertil Steril. 2005 Sep;84(3):682-6.

Office Based Evaluation of Patients Presenting With Abnormal Uterine Bleeding and/or Uterine Fibroids With Concurrent Office Hysteroscopy and Endometrial Biopsy; Does the Order Matter?

Details for clinical trial NCT02472184

Clinical trial NCT02472184 - References