Clinical Trials Resource Center

Pregnancy

January 16, 2017

Agile Therapeutics issued results of a phase III trial of Twirla, a low-dose combined hormonal contraceptive patch. SECURE was a multicenter, single-arm, open-label, 13-cycle trial that evaluated the safety, efficacy and tolerability of Twirla in 2,032 healthy women, aged 18 and over. Of those enrolled, 51.4% of subjects discontinued prematurely from the study and the loss to follow-up rate was 11.3%, which is in line with loss to follow-up rates observed in previous clinical trials of combined hormonal products, and substantially better than the 20% loss to follow-up rate observed in the company’s previous phase III trial. The Pearl Index for the overall intent to treat population of subjects 35 years of age and under was 4.80 with an upper-bound of the 95% confidence interval of 6.06. As with all hormonal contraceptive trials, the number of pregnancies included in Agile’s calculation of the Pearl Index is subject to review by the FDA as part of its overall review of the NDA for Twirla. Consistent with other recent hormonal contraceptive clinical trials, including Ortho Evra and Quartette, and the FDA’s 2015 meta-analysis on the effect of obesity on the effectiveness of hormonal contraceptives, a relationship between obesity and efficacy was observed among subjects 35 years of age and under. Twirla was generally well-tolerated and had an overall favorable safety profile, consistent with publicly available information relating to other low-dose combined hormonal products. The most frequent hormone-related adverse events, none of which were experienced by more than 5% of subjects, were generally in line with those events observed in other low dose combined hormonal products.

April 28, 2008

GlaxoSmithKline and Protherics reported mixed results from a phase IIb trial of Digibind for the treatment of pre-eclampsia. This parallel-group, double-blind, placebo-controlled, randomized study was dubbed DEEP (Digoxin Immune Fab (DIF) Efficacy Evaluation in Pre-eclampsia). It enrolled fifty-one women with severe pre-eclampsia who were in the twenty-fourth through thirty-fourth week of pregnancy, and for whom delivery of the baby was considered necessary within seventy-two hours. The subjects received either Digibind or placebo every six hours for up to forty-eight hours. The two primary endpoints were creatinine clearance, a measure of kidney function, and the use of antihypertensive medication to lower blood pressure. The DEEP study met the first endpoint; the deterioration in kidney function during the 24-48 hours period of treatment was significantly less (p<0.05) in subjects receiving Digibind compared to subjects receiving placebo. However, there was no significant difference for the other primary endpoint, the use of antihypertensive drugs. Based on the results the companies planned to conduct a full analysis of the data in order to determine the future course of action.

August 27, 2007

Medicinova issued positive results from a phase Ib trial of MN-221 for the treatment of pre-term labor. This trial enrolled 10 healthy, pregnant subjects who were not in labor. The subjects received a single-dose intravenous infusion regimen of MN-221, consisting of two consecutive rounds of a 15-minute priming and a 105-minute maintenance infusion to deliver 294 micrograms of MN-221 over four hours. The primary endpoints included pharmacokinetics, safety and tolerability. Treatment was safe and well tolerated, with no reported serious adverse events. In addition, target plasma concentrations were achieved with an intravenous priming followed by maintenance infusion dosing paradigm. Based on the results, Medicinova plans to move forward with development.

July 30, 2007

Alliance reported positive results from a phase III trial of Isprelor for the induction of labor. This trial enrolled 600 women who received Isprelor (25 mg) or dinoprostone (standard of care). The study met the primary endpoint of non-inferiority. The two treatments were similarly efficacious, with no statistical difference between Isprelor and dinoprostone in the ability to produce a vaginal delivery within 24 hours of commencing treatment. No unexpected adverse events occurred and Isprelor was shown to be no more likely than dinoprostone to cause hyperstimulation of the uterus. Based on the results, Alliance planned to file for European approval in the second half of 2008.

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