January 25, 2010
Antares and The Population Council reported positive results from a phase II trial of NES/E2, a transdermal contraceptive gel containing the progestin nestorone and estradiol. This dose-finding, open-label, cross-over study enrolled 18 healthy, ovulating female subjects across three international sites. All subjects received each of three separate doses of the gel for 21 days, separated by a washout month in which no products were administered when they recovered normal ovulation. The primary objective was to find the lowest acceptable dose of the NES/E2 gel to achieve appropriate therapeutic levels for effective contraception, as measured by progesterone levels and ultrasound evaluation of follicular development. The gel was able to suppress ovulation at all doses tested. The optimal dose, that which gave the most stable levels of hormones, was also determined. No serious adverse events or instances of skin irritation were recorded.
September 8, 2008
Agile Therapeutics released positive results from two clinical studies of AG-200-15, a seven-day contraceptive patch. The first study was an open-label, randomized, comparative, single-center, two-period cross-over pharmacokinetic trial. It enrolled 39 subjects and was designed to evaluate two contraceptive patches to see if the systemic exposure of the hormones in AG-200-15 (ethinyl estradiol and levonorgestrel) were comparable to the low-dose oral contraceptive, Levlen. Data showed that the exposure over time of both hormones in the two patches were less than Levlen and consistent with the target doses. The second study was a phase IIb multi-center, multi-cycle safety and efficacy study. It enrolled 123 subjects who received one of three patches with different estrogen and progestin doses, for three cycles. The study was designed to identify the regimen providing the best efficacy (as demonstrated by ovulation suppression), cycle control and tolerability at the lowest hormonal dose. Top-line results showed a clear dose-response to ovulation suppression and cycle control. AG-200-15 provided the greatest ovulation suppression with the best cycle control of the three regimens studied. Based on the results, Agile Therapeutics plans to meet with the FDA to discuss a phase III trial design.
August 20, 2007
Sosei announced positive results from a phase I trial of NorLevo, an emergency contraceptive pill. This randomized, double blind, placebo-controlled trial enrolled 33 healthy, adult women in Japan. The subjects were placed into three dose cohorts. The first dose of NorLevo was administered within 72 hours after unprotected sexual intercourse, with a second dose administered 12 to 24 hours later. All primary and secondary safety and pharmacokinetic endpoints were met. Treatment with NorLevo was well tolerated and showed an excellent pharmacokinetic profile. Based on the results, Sosei plans to advance NorLevo into further clinical trials.
July 9, 2007
Acrux reported positive results from two phase I trials of Nestorone, a contraceptive skin spray. The first trial enrolled healthy subjects and was designed to assess the pharmacokinetics of Nestorone combined with Ethinyl Estradiol, a synthetic estrogen. The second trial also enrolled healthy subjects and was designed to evaluate the pharmacokinetics of Nestorone combined with Estradiol, a natural estrogen. Subjects received a single dose of the combination formulation applied to the forearm. Results showed effective delivery of both contraceptive agents, with blood concentrations of Nestorone and Ethinyl Estradiol and Estradiol in the target range expected to provide effective contraception. The spray was well tolerated, with no adverse events reported. Based on the results, Acrux plans to proceed with a multi-dose phase I trial in the second half of 2007.
February 18, 2003
Agile Therapeutics reported positive results from a phase II trial investigating their 7-day contraceptive patch. Results indicated that ovulation was suppressed by more than 95% throughout three months of study. Results also showed lower than expected hormone-induced side effects and demonstrated an overall tolerability profile similar to predictions. The trial evaluated 225 menstrual cycles in which a translucent transdermal patch was applied for the first three weeks and was followed by one week with the patch removed. The contraceptive patch delivers a combination of the drugs levonorgestrel and ethinylestradiol.
May 20, 2002
Biosyn reported positive results from two phase I/II trials of Savvy (C31G intravaginal gel), an investigational product for contraception and the prevention of sexually transmitted diseases (STDs). In a phase I/II dose escalation study, 64 women used Savvy gel in single and multiple doses for two weeks. Data showed that the trial met primary endpoints of safety and acceptability. The second trial was a post-coital testing (PCT) study that evaluated the safety and efficacy of three concentrations of Savvy. The primary endpoints of safety and spermicidal efficacy were met with Savvy administration prior to intercourse.
May 13, 2002
Positive results were reported from a phase III trial of Barr Laboratories' Seasonale extended oral contraceptive. The randomized, four-arm, open-label, multicenter trial included approximately 1,400 women between the ages of 18 and 40. Subjects received Seasonale (one of two dose levels: 0.15 mg levonorgestrel/0.03 mg ethinyl estradiol or 0.10 mg levonorgestrel/0.02 mg ethinyl estradiol), Nordette 28-day tablets (0.15 mg levonorgestrel/0.03 mg ethinyl estradiol), or Levlite 28-day tablets (0.10 mg levonorgestrel/0.02 mg ethinyl estradiol). Results demonstrated that both levels of Seasonale prevented pregnancy comparable to Nordette and Levlite in women between the ages of 18 and 35. The company anticipates filing an NDA for Seasonale in mid-2002.