NCT02562053 - 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)

Lopez LM, Kaptein AA, Helmerhorst FM
Oral contraceptives containing drospirenone for premenstrual syndrome. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD006586. doi: 10.1002/14651858.CD006586.pub4. Review.
Marjoribanks J, Brown J, O'Brien PM, Wyatt K
Selective serotonin reuptake inhibitors for premenstrual syndrome. Cochrane Database Syst Rev. 2013 Jun 7;(6):CD001396. doi: 10.1002/14651858.CD001396.pub3. Review.
Steiner M, Brown E, Trzepacz P, Dillon J, Berger C, Carter D, Reid R, Stewart D
Fluoxetine improves functional work capacity in women with premenstrual dysphoric disorder. Arch Womens Ment Health. 2003 Feb;6(1):71-7.
Yonkers KA
Management strategies for PMS/PMDD. J Fam Pract. 2004 Sep;Suppl:S15-20. Review.

Does Adding Combined Oral Contraceptives to Fluoxetine Improve the Management of Premenstrual Syndrome? A Double Blind Placebo Controlled Study.

Clinical trial NCT02562053 - References