Ovumine is a prescription drug and therefore the work-up and treatment of candidates for ovumine therapy should be supervised by physicians experienced in the management of gynecologic or endocrine disorders. Patients should be selected for therapy with Ovumine only after careful diagnostic evaluation.
Chemically, Ovumine is a nonsteroidal triphenylethylene derivative that exhibits both estrogen agonist and antagonist properties. In general, estrogen agonist properties are manifest only when the endogenous estrogen levels are extremely low. Otherwise, Ovumine acts solely as a competitive estrogen antagonist. Ovumine is cleared through the liver and excreted in stool
Ovumine is a racemic mixture of the two distinct stereoisomers of clomiphene citrate, enclomiphene and zuclomiphene. Available evidence indicates that enclomiphene is the more potent isomer and the one primarily responsible for the ovulatory inducing actions of Ovumine. Enclomiphene level rises rapidly after administration and falls to undetectable concentrations soon thereafter. Zuclomiphene is cleared far more slowly. Levels of this less active isomer remain detectable in circulation for more than a month after treatment and may accumulate over consecutive cycles of treatment, but there is no evidence of any important clinical consequences.
Mode of Action
Structural similarity to estrogen allows Ovumine to bind to estrogen receptors (ER) throughout the reproductive system. However, in contrast to estrogen, Ovumine binds nuclear ER for an extended period of time and ultimately depletes ER concentration by interfering with the normal process of ER replenishment. Ovumine’s effectiveness in ovulation induction can be attributed to actions at the hypothalamic level. Depletion of hypothalamic ER prevents correct interpretation of circulating estrogen levels. Reduced levels of estrogen negative feedback trigger normal compensatory mechanisms that alter pulsatile hypothalamic gonadotropin releasing hormone (GnRH) secretion to simulate increased pituitary gonadotropin release, which in turn, drives ovarian follicular activity.
Ovumine is indicated in:
- Luteal Phase Deficiency: Given that the corpus luteum is derived from the follicle that ovulates, its functional capacity is, at least in part, dependent on the quality of preovulatory follicle development. In that context, Ovumine is one logical treatment option for luteal phase deficiency (LPD)
- Unexplained infertility: In couples whose infertility remains unexplained after careful and thorough evaluation, empiric treatment with Ovumine may be justified, particularly in young couples with a short duration of infertility. The efficacy of empiric Ovumine treatment may be attributed to correction of subtle and unrecognized ovulatory dysfunction and /or “superovulation” of more than a single ovum. Ovumine treatment is most effective when it is combined with properly timed intrauterine insemination (IUI), all in an effort to bring together more than the usual numbers of ova and sperm at the optimal time.
- Oligospermia: Ovumine exerts its effect on spermatogenesis by raising the endogenous serum FSH, LH and testosterone levels to initiate and maintain gametogenesis. Researchers opined that this increase in endogenous gonadotropins manifest itself in improving the sperm count, sperm motility and to certain extent morphology of the sperm, when there is no end-organ pathology.
Ovumine is administered orally. The recommended dose for the first course of therapy is 50mg (1 tablet) daily for 5 days. Treatment should start on the second or third day of menses. If ovulation appears not to have occurred after the first course of therapy, a second course of 100mg daily (two 50mg tablets given as a single daily dose) for 5 days should be given. This course may be started as early as 30 days after the previous one. Increasing the dosage or the duration of the therapy beyond 100mg/day for 5 days should never be undertaken.
Ovumine should not be administered when any of the following is present:
- Liver disease
- Hormone-dependent tumours or abnormal uterine bleeding
- Ovarian cyst
Ovumine is generally very well tolerated. Some side effects are relatively common, but rarely are they persistent or severe enough to threaten completion of the usual 5-day course or next cycle of treatment. The following side effects have been observed:
- Vasomotor flushes (hot flashes) occur in approximately 10% of Ovumine-treated women, but typically abate soon after treatment ends.
- Mood swings are also common.
- Visual disturbances, including blurred or double vision.