Contraception — Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study
Citation(s)
ACOG practice bulletin no 105: bariatric surgery and pregnancy. Obstet Gynecol. 2009 Jun;113(6):1405-1413. doi: 10.1097/AOG.0b013e3181ac0544. No abstract available.
Archer DF, Ahrendt HJ, Drouin D Drospirenone-only oral contraceptive: results from a multicenter noncomparative trial of efficacy, safety and tolerability. Contraception. 2015 Nov;92(5):439-44. doi: 10.1016/j.contraception.2015.07.014. Epub 2015 Jul 29.
Creinin MD, Angulo A, Colli E, Archer DF The efficacy, safety, and tolerability of an estrogen-free oral contraceptive drospirenone 4 mg (24/4-day regimen) in obese users. Contraception. 2023 Dec;128:110136. doi: 10.1016/j.contraception.2023.110136. Epub
Duijkers IJ, Heger-Mahn D, Drouin D, Skouby S A randomised study comparing the effect on ovarian activity of a progestogen-only pill (POP) containing desogestrel and a new POP containing drospirenone in a 24/4 regimen. Eur J Contracept Reprod Health Care
Han L, Creinin MD, Hemon A, Glasier A, Chen MJ, Edelman A Mechanism of action of a 0.075 mg norgestrel progestogen-only pill 2. Effect on cervical mucus and theoretical risk of conception. Contraception. 2022 Aug;112:43-47. doi: 10.1016/j.contraception.2
Jane Ellis M, Livesey JH, Evans MJ Hormone stability in human whole blood. Clin Biochem. 2003 Mar;36(2):109-12. doi: 10.1016/s0009-9120(02)00440-x.
Jick H, Jick SS, Gurewich V, Myers MW, Vasilakis C Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components. Lancet. 1995 Dec 16;346(8990):1589-93. doi: 10.1016/s
Krepelka P New estrogen-free oral hormonal contraceptive (Estrogene free ill-EFP). Ceska Gynekol. 2020 Winter;85(3):222-225.
Landgren BM, Unden AL, Diczfalusy E Hormonal profile of the cycle in 68 normally menstruating women. Acta Endocrinol (Copenh). 1980 May;94(1):89-98. doi: 10.1530/acta.0.0940089. No abstract available.
Moghissi KS, Marks C Effects of microdose norgestrel on endogenous gonadotropic and steroid hormones, cervical mucus properties, vaginal cytology, and endometrium. Fertil Steril. 1971 Jul;22(7):424-34. doi: 10.1016/s0015-0282(16)38342-x. No abstract avai
Palacios S, Colli E, Regidor PA Efficacy and cardiovascular safety of the new estrogen-free contraceptive pill containing 4 mg drospirenone alone in a 24/4 regime. BMC Womens Health. 2020 Oct 2;20(1):218. doi: 10.1186/s12905-020-01080-9.
Simmons K, Edelman A Contraception in the setting of obesity and bariatric surgery. In: Allen RH, Cwiak CA, editors. Contraception for the medically challenging patient. New York: Springer; 2014. P. 157-80.
Trevor G Cooper WHO laboratory manual for the Examination and processing of human semen.5th ed. Switzerland: WHO; 2010. Appendix 5, Cervical mucus; p. 245-53.
Tworoger SS, Hankinson SE Collection, processing, and storage of biological samples in epidemiologic studies: sex hormones, carotenoids, inflammatory markers, and proteomics as examples. Cancer Epidemiol Biomarkers Prev. 2006 Sep;15(9):1578-81. doi: 10.1
Vasilakis C, Jick H, del Mar Melero-Montes M Risk of idiopathic venous thromboembolism in users of progestagens alone. Lancet. 1999 Nov 6;354(9190):1610-1. doi: 10.1016/S0140-6736(99)04394-9.
Wathen NC, Perry L, Lilford RJ, Chard T Interpretation of single progesterone measurement in diagnosis of anovulation and defective luteal phase: observations on analysis of the normal range. Br Med J (Clin Res Ed). 1984 Jan 7;288(6410):7-9. doi: 10.1136
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
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.
