Columbia Laboratories Inc announced positive results of an 88-patient randomized, open-label pilot study evaluating the efficacy, safety and tolerability of Prochieve 8 per cent (progesterone gel) and oral estradiol hormone supplementation in conjunction with clomiphene citrate on conception rates in timed intercourse cycles.
Of the 71 evaluable patients, 34 women were treated with clomiphene citrate followed by oral estradiol and Prochieve 8 per cent (CEP Regimen), while 37 received clomiphene citrate alone. Cycle one data demonstrated a clinically meaningful trend for pregnancy rates in the CEP Regimen arm, which were more than double the control arm. This single-centre pilot study was stopped before full enrolment so that the data could be assessed and a multi-centre trial could be designed.
"The pregnancy rates achieved in this study demonstrate the benefits of using a sequential estrogen and progesterone supplementation regimen with Prochieve 8 per cent for clomiphene citrate cycles in oligo-ovulatory and anovulatory women," stated Karen E Elkind-Hirsch, scientific director of research, Woman's Health Research Institute, Woman's Hospital, Baton Rouge, LA and the lead investigator of this study.
"Though the data did not achieve statistical significance, these clinically significant pilot data showing a higher pregnancy rate with the CEP Regimen extend the findings from our prior biopsy study, in which the CEP Regimen corrected the endometrial abnormalities seen in clomiphene citrate cycles," Karen added.
Fred Wilkinson, chairman, president and CEO of Columbia Laboratories, said, "Our patented progesterone gel has been used by OB/GYNs and fertility specialists to help infertile women safely and effectively achieve and sustain pregnancy in the first trimester since its market introduction in 1997. We are very pleased with the clinically meaningful outcome demonstrated in this pilot study, a doubling of pregnancy rates with Prochieve 8 per cent. We look forward to presenting full results of this study at appropriate scientific forums and to further evaluating the CEP Regimen in a larger, multi-centre study."
This study enrolled 88 women, 21 to 35 years of age, whose confirmed anovulatory and oligo-ovulatory condition would typically lead to fertility treatments. All patients were treated with 100 mg clomiphene citrate orally for Days 3 to 7 of the cycle. Starting on Day 8, patients in the CEP Regimen arm also received 3 mg oral estradiol twice daily until detection of a surge in luteinizing hormone (LH) levels. Intercourse was encouraged starting on Day 10. Three days after the LH surge, patients in the CEP Regimen arm began treatment with Prochieve 8 per cent (progesterone gel); daily use of Prochieve 8 per cent continued for two weeks, followed by a pregnancy test. If pregnant, all patients in the CEP Regimen arm received Prochieve 8 per cent for an additional 10 weeks.
Prochieve 8 per cent (progesterone gel) is a bio-adhesive product that is approved by the US FDA for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency.
Columbia Laboratories Inc is a US-based international pharmaceutical company involved in the development and commercialization of women's health care and endocrinology products, including those intended to treat infertility, dysmenorrhea, endometriosis and hormonal deficiencies.