Induction of ovulation in human with ovulatory failure has been a problem of research interest for several decades. Despite various hormonal regimens tried in the past, satisfactory results were rarely achieved. CLOMIPHENE CITRATE - an effective ovulatory drug in humans. Chiesi is addressing pathologies of infertility which are as follows:
Normal and regular ovulation is essential for women to conceive naturally. The most common disorders impacting ovulation include polycystic ovary syndrome (PCOS)
Tubal occlusion (blockage):
History of sexually transmitted infections including gonorrhea, or pelvic inflammatory disease can predispose a woman to having blocked fallopian tubes. Tubal occlusion is a cause of infertility because an ovulated egg is unable to be fertilized by sperm or to reach the endometrial cavity. If both tubes are blocked, then in vitro fertilization (IVF) is required
Endometrial polyps are finger-like growths in the uterine cavity arising from the lining of the uterus, called the endometrium.
Endometriosis is a condition whereby cells very similar to the ones lining the uterine cavity, or endometrium, are found outside the uterine cavity.
Number of years ago in 1960, a week synthetic estrogen was developed as an anti-infertility drug. This was TRIPARA -ANISYLCHLORO- ETHYLENE. A derivative of this drug was CLOMIPHENE CITRATE - an effective ovulatory drug in humans. Clomiphene citrate has been the most widely used treatment for fertility enhancement for the past 35 years.
Prolifen (Clomiphene Citrate) Acts As A Competitive Inhibitor Of Estrogen, Blocking Estrogen At The Hypothalamic Level, Thus Removing The Inhibition To Pituitary Gonadotropin Production And Allowing A Gonadotrophic Flood. The Increased Gonadotropin Secretion Causes Excessive Ovarian Stimulation, with Excretion of Urinary Estrogen, Ovulation and Normal Corpusluteum Function
Dosage and Administration
The recommended dose for first treatment cycle with PROLIFEN is 50 mg (1 capsule) daily for 5 days. When ovulation occurs at this dosage there is no advantage in increasing the dose in subsequent cycles of treatment.
If ovulation occurs at this dosage but is not followed by pregnancy, subsequent courses for a total maximum of 6 cycles of PROLIFEN treatment may be administered. If ovulation does not occur after first course of therapy a second course of 100 mg daily (two 50 mg capsules given as two daily doses) for five days should be given. If ovulatory menses do not occur, this dose may be repeated for two additional cycles, but failure to induce ovulation after 3 consecutive cycles at this dosage should constitute an adequate therapeutic trial. The importance of properly timed coitus should be over-emphasized. Therapy may be started at any time in a patient who has had no recent uterine bleeding, but if progestin-induced bleeding is planned, or if spontaneous uterine bleeding occurs prior to therapy, the cycle with PROLIFEN should be started on or about the fifth day of the cycle.