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Crinone 8% Bioadhesive Gel Delivers Higher Uterine Levels Than IM Progesterone

  • Clinical studies show comparable pregnancy rates despite differences in serum progesterone levels1–3
Study design: Results of a randomized, open-label study in 14 postmenopausal women who were undergoing hysterectomy. Patients were equally randomized to receive 3 doses of Crinone 8% (90 mg) or IM progesterone (50 mg) prior to surgery. Samples of the endometrium were obtained following hysterectomy and blood samples were taken prior to and during surgery.

 

  • Serum progesterone levels do not accurately reflect levels in the endometrium5

Accurate, unique delivery system

  • Vaginal applicator allows direct delivery of prescribed dose in a single, daily application
  • Bioadhesive gel provides sustained, controlled release for dependable delivery6

References: 1. Williams SC, Donahue J, Muasher SJ. Vaginal progesterone therapy during programmed cycles for frozen embryo transfer: an analysis of serum progesterone levels and pregnancy rates. Fertil Steril. 2000;74(suppl 1):S209. Abstract P-363. 2. Anserini P, Costa M, Remorgida V, Sarli R, Guglielminetti E, Ragni N. Luteal phase support in assisted reproductive cycles using either vaginal (Crinone 8) or intramuscular (Prontogest) progesterone: results of a prospective, randomized study [in Italian]. Minerva Ginecol. 2001;53:297–301. 3. Chantilis SJ, Zeitoun KM, Patel SI, et al. Use of Crinone vaginal progesterone gel for luteal support in in vitro fertilization cycles. Fertil Steril. 1999;72:823–829. 4. Cicinelli E, De Ziegler D, Bulletti C, Matteo MG, Schonauer LM, Galantino P. Direct transport of progesterone from vagina to uterus. Obstet Gynecol. 2000;95:403–406. 5. Gibbons WE, Toner JP, Hamacher P, Kolm P. Experience with a novel vaginal progesterone preparation in a donor oocyte program. Fertil Steril. 1998;69:96–101.

 

Important Safety Information

The most common side effects of CRINONE (progesterone gel) 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. CRINONE 8% is contraindicated in patients with active, or a history of, thrombophlebitis or thromboembolic disorders, patients who have known sensitivity to CRINONE 8%, missed abortion, undiagnosed vaginal bleeding, liver dysfunction or disease, and known or suspected malignancy of the breast or genital organs. Should any of the earliest manifestations of thrombotic disorders occur, the drug should be discontinued immediately. No adequate evidence is available to show that progesterone and progestins are effective in preventing miscarriage in women with a history of recurrent spontaneous pregnancy losses. The pretreatment physical exam should include special reference to breast and pelvic organs as well as a Papanicolaou smear. Nonfunctional causes of breakthrough bleeding should be considered, and for undiagnosed vaginal bleeding, diagnostic measures should be undertaken. Special care should be taken with patients who have conditions that may be influenced by fluid retention, those who have a history of psychic depression, and those with diabetes.