NCT03567655 - 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)

Bokhman JV, Chepick OF, Volkova AT, Vishnevsky AS
Can primary endometrial carcinoma stage I be cured without surgery and radiation therapy? Gynecol Oncol. 1985 Feb;20(2):139-55.
Kempson RL, Pokorny GE
Adenocarcinoma of the endometrium in women aged forty and younger. Cancer. 1968 Apr;21(4):650-62.
Park JY, Nam JH
Progestins in the fertility-sparing treatment and retreatment of patients with primary and recurrent endometrial cancer. Oncologist. 2015 Mar;20(3):270-8. doi: 10.1634/theoncologist.2013-0445. Epub 2015 Feb 11. Review.
Skouby SO
The rationale for a wider range of progestogens. Climacteric. 2000 Dec;3 Suppl 2:14-20. Review.

Phase II Study of Fertility-sparing Management Using High-dose Oral Progestin in Young Women With Stage I Endometrial Adenocarcinoma With Grade 2 Differentiation or Superficial Myomectomy Invasion

Details for clinical trial NCT03567655

Clinical trial NCT03567655 - References