Repronex (Menotropins) - Summary

REPRONEX SUMMARY

Repronex® (menotropins for injection, USP) is a purified preparation of gonadotropins extracted from the urine of postmenopausal women. Each vial of Repronex® contains 75 International Units (IU) or 150 IU of follicle-stimulating hormone (FSH) activity and 75 IU or 150 IU of luteinizing hormone (LH) activity, respectively, plus 20 mg lactose monohydrate in a sterile, lyophilized form. The final product may contain sodium phosphate buffer (sodium phosphate tribasic and phosphoric acid). Repronex® is administered by subcutaneous or intramuscular injection. Human Chorionic Gonadotropin (hCG), a naturally occurring hormone in post-menopausal urine, is detected in Repronex®.

Repronex®, in conjunction with hCG, is indicated for multiple follicular development (controlled ovarian stimulation) and ovulation induction in patients who have previously received pituitary suppression.

1. Before treatment with Repronex® is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. Except for those patients enrolled in an in vitro fertilization program, this should include a hysterosalpingogram (to rule out uterine and tubal pathology) and documentation of anovulation by means of basal body temperature, serial vaginal smears, examination of cervical mucus, determination of serum (or urine) progesterone, urinary pregnanediol and endometrial biopsy. Patients with tubal pathology should receive menotropins only if enrolled in an in vitro fertilization program.
2. Primary ovarian failure should be excluded by the determination of gonadotropin levels.
3. Careful examination should be made to rule out the presence of an early pregnancy.
4. Patients in late reproductive life have a greater predilection to endometrial carcinoma as well as a higher incidence of anovulatory disorders. Cervical dilation and curettage should always be done for diagnosis before starting Repronex® therapy in such patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities.
5. Evaluation of the husband's fertility potential should be included in the workup.

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NEWS HIGHLIGHTS

Published Studies Related to Repronex (Menotropins)

Evaluation of mixed protocols with Bravelle (human-derived FSH) and Repronex (hMG) to assess clinical efficacy (EMBRACE) in women undergoing in vitro fertilization. [2004.08]
OBJECTIVE: To compare the efficacy and safety of three different ratios of human-derived follicle-stimulating hormone/human menopausal gonadotropin (human-derived FSH:hMG, Bravelle and Repronex) mixed together in the same syringe and administered subcutaneously once daily, to in vitro fertilization (IVF) patients <34 years or 34 to 40 years of age...

Subcutaneously administered Repronex in oligoovulatory female patients undergoing ovulation induction is as effective and well tolerated as intramuscular human menopausal gonadotropin treatment. [2001.07]
OBJECTIVE: To determine the efficacy and safety of Repronex SC as compared with Repronex IM and Pergonal IM in patients undergoing ovulation induction.

Luteinzing hormone activity in menotropins optimizes folliculogenesis and treatment in controlled ovarian stimulation. [2001.01]
Although the role that LH plays in folliculogenesis is still controversial, recent evidence points toward facilitatory actions of LH activity in ovulation induction. Thus, we compared the response to either highly purified FSH (75 IU FSH/ampoule; group A, 25 subjects) or human menopausal gonadotropin (75 IU FSH and 75 IU LH/ampoule; group B, 25 subjects) in normoovulatory GnRH agonist-suppressed women, candidates for intrauterine insemination...

Subcutaneously administered Repronex in female patients undergoing in vitro fertilization is as effective and well tolerated as intramuscular menotropin treatment. Repronex SC, IVF Study Group. [2000.07]
OBJECTIVE: To determine the efficacy and safety of Repronex SC as compared with Repronex IM and Pergonal IM in patients undergoing IVF...

Menotropins alone are superior to a clomiphene citrate and menotropin combination for superovulation induction among clomiphene citrate failures. [1996.06]
OBJECTIVE: To examine the difference in efficacy between two protocols of superovulation induction with IUI among infertile couples... CONCLUSION: For patients undergoing superovulation with IUI, a menotropin-alone protocol yields significantly higher pregnancy rates than one using a combination of menotropin with CC. These differences could not be explained by patient characteristics. Among cycle performance parameters, endometrial thickness and pattern differed significantly between the two groups.

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Clinical Trials Related to Repronex (Menotropins)

Menopur Mixed Protocol [Recruiting]
Subjects undergoing Assisted Reproductive Technology will self-administer Menopur and Bravelle mixed in the same syringe or Menopur alone. The study will assess the subject's ability to mix and store the combination of Menopur and Bravelle and to assess safety of the Menopur and Bravelle combination.

Effect of GnRH Antagonist vs Agonist Long on IVF Outcome, Peak Estradiol Level,and Duration of Stimulation [Recruiting]
The purpose of this study is to determine if utilizing GnRH antagonists versus agonist long protocol during controlled ovarian stimulation (COH) with human-derived gonadotropins for assisted reproduction affects IVF outcome, peak estradiol level, and duration of stimulation.

MENOPUR® Versus FOLLISTIM® [Recruiting]
To compare the efficacy and safety of MENOPUR® with that of FOLLISTIM® in patients who are undergoing GnRH antagonist IVF cycles

Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS) [Recruiting]
This multicenter, randomized, open-label exploratory study will be performed in approximately 200 PCOS but otherwise healthy females undergoing IVF. Each study center will follow its standard practice for IVF within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned to Menopur® or Follistim Pen® for stimulation and Endometrin® or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per IVF protocol at the site and at specified times during the cycle (Stimulation Day 6, Day of hCG, and first serum pregnancy test) for estradiol (E2), progesterone (P4) and hCG labs. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.

A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa [Recruiting]

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