E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Increased-Risk for Preterm Delivery |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
A reduction in the frequency of delivery at ≤32 0/7 weeks gestational age in subjects who have had a previous preterm delivery. |
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E.2.2 | Secondary objectives of the trial |
1.Frequency of delivery at ≤32 0/7 weeks gestational age in subjects who have had a previous preterm delivery or only a short cervix (≤ 2.5 cm). 2. Frequency of delivery at ≤ 28 0/7 weeks, ≤ 35 0/7 weeks, and ≤ 36 6/7 weeks gestation. 3. Frequency of delivery at ≤ 32 0/7 weeks gestation in both compliant subjects and non-compliant subjects. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. The subject has a history of a documented spontaneous singleton preterm delivery (hospital or clinic record, letter from healthcare provider, or birth certificate) from 20 0/7 to 35 0/7 weeks gestational age with the immediate preceding pregnancy or has a cervical length of 2.5 cm or less measured by transvaginal ultrasound with the current pregnancy. “Spontaneous preterm delivery" is a delivery (<35 weeks), either vaginal or cesarean, that is initiated by either preterm PROM followed by contractions or preterm labor initiated with in-tact membranes. A previous preterm delivery secondary to an incompetent cervix where a cerclage is considered for this pregnancy is not considered a preterm delivery (please see Exclusion Criteria No. 10). Subjects enrolled based on a history of preterm delivery may have had a pregnancy loss (or losses) at <20 0/7 weeks gestational age between the preceding preterm delivery and the current pregnancy. 2. The female subject is between 18 and 45 years of age at the time of screening. 3. The pregnancy has an estimated gestational age between 16 0/7 weeks and 22 6/7 weeks. 4. The subject speaks either English or a common local language. 5. The subject has voluntarily signed the Informed Consent Form and associated forms after having the contents explained, and all her questions are answered to her satisfaction and understanding. 6. In the opinion of the investigator, the subject is able to understand the study and is able to give informed consent, as well as participate in it and adhere to study procedures. |
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E.4 | Principal exclusion criteria |
1. The subject has a previous history of an adverse reaction to progesterone or any component present in Prochieve® 8% vaginal gel. 2. The subject has been treated with a progestogen within the previous 4 weeks. 3. The subject is currently being treated for a seizure disorder, has an unstable psychiatric disorder, is taking antihypertensive therapy for chronic hypertension at the time of enrollment, has a history of congestive heart failure or chronic renal failure, or has uncontrolled diabetes mellitus (known end-organ dysfunction secondary to vascular disease). 4. The subject has active thrombophlebitis or a thromboembolic disorder, or a history of hormone-associated thrombophlebitis or thromboembolic disorders. 5. The subject has liver dysfunction or disease. 6. The subject has known or suspected malignancy of the breast. 7. The subject is currently participating in another investigational study or has participated in an investigational drug study within one month prior to screening for this study. 8. The subject’s current pregnancy is complicated by a major fetal anomaly or known chromosomal abnormality. 9. The subject has a uterine anatomic malformation (bicornuate uterus, septate uterus) 10. The subject has a multifetal gestation. 11. The subject has a cervical cerclage in place or has plans to have one placed during the current pregnancy. 12. The subject, in the judgment of the investigator, will be unable or unwilling to comply with study-related assessments and procedures. 13. The subject currently has preterm rupture of membranes, vaginal bleeding, known or suspected amnionitis, or signs or symptoms of preterm labor at the time of enrollment. 14. The subject is HIV positive with a CD4 count of ≤350 cells/mm3 and is receiving more than 1 medication to prevent the transfer of AIDS to the fetus. 15. The subject has placenta previa or a low-lying placenta. The subject will be considered for the study if she is not at risk for increased bleeding and has not been given any vaginal precautions. 16. The subject’s qualifying preterm delivery was an indicated delivery without preterm labor (i.e. delivery performed for fetal distress, maternal eclampsia/preeclampsia, fetal death, or amnionitis in the absence of contractions). |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy parameter in this study is the proportion of subjects with a delivery ≤ 32 0/7 weeks gestational age in subjects who have had a previous preterm delivery. A supplemental parameter in this study is the frequency of significant morbidity in infants during the initial hospitalization after birth. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |