Phase 3
N=108
A Phase III Study of FE 999913 in Japanese Female Patients Undergoing Fertility Treatment
Luteal Hormone Supplementation
Bottom Line
View on ClinicalTrials.gov: NCT01710514 ↗Enrolled (actual)
108
Serious AEs
0.9%
Results posted
Aug 2014
Primary outcome: Primary: The Proportion of Subjects With Blood Progesterone Concentration Not Less Than 10 ng/ml — 98.9 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- FE 999913 vaginal tablet (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Subjects With Blood Progesterone Concentration Not Less Than 10 ng/ml |
98.9 | — |
| PRIMARY Ongoing Pregnancy Rate |
14.0; 29.8; 22.2 | — |
| SECONDARY Rate of Positive βeta Human Chorionic Gonadotrophin (βhCG) |
16.3; 27.7; 22.2 | — |
| SECONDARY Clinical Pregnancy Rate |
14.0; 29.8; 22.2 | — |
| SECONDARY Blood Progesterone Concentration |
0.626; 0.704; 0.666; 11.4; 30.7; 22.3 | — |
Summary
The purposes of the study are to verify sufficient supplementation of luteal hormone after administrating FE999913 Vaginal Tablet twice a day (BID) or three times a day (TID) and to determine the efficacy and safety of FE999913 Vaginal Tablet in Japanese women undergoing fertility treatment with IVF-ET (a fresh embryo transfer).
Eligibility Criteria
Inclusion Criteria
- Pre-menopausal adult women between the ages of 20 and 42 years.
- Early follicular phase (day 2-4) follicle stimulating hormone (FSH) ≤12 IU/L and Estradiol 34 at time of Screening.
- Previous IVF or ART failure due to a poor response to gonadotropins*.
- Defined as development of ≤2 mature follicles or history of 2 previous cycle cancellations prior to oocyte retrieval due to poor response.
- Presence of abnormal uterine bleeding of undetermined origin.
- Current or recent (within the past 12 months) substance abuse, including alcohol.
- Known or suspected breast or genital tract cancer.
- History of chemotherapy or radiotherapy for malignant disorder (chorionic disease).
- Currently breast feeding, pregnant or contraindication to pregnancy.
- Refusal or inability to comply with the requirements of the Protocol for any reason, including scheduled visits and clinical laboratory tests.
- Documented intolerance or allergy to any of the medications to be used in the study including the investigational medicinal product.
- Participation in any experimental drug study within 60 days prior to Screening.
- Use of any of the following medications during the pretreatment and treatment phase: hormonal drug products (use of oral contraceptives prior to start of controlled ovarian stimulation is allowed), other progesterone drug products, hydrocortisone and other steroid drug products, and fertility modifiers such as insulin sensitizers.
- History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages.
Data sourced from ClinicalTrials.gov (NCT01710514). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.