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A Phase III Study of FE 999913 in Japanese Female Patients Undergoing Fertility Treatment

Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Luteal Hormone Supplementation

Intervention: FE 999913 vaginal tablet (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Ferring Pharmaceuticals

Official(s) and/or principal investigator(s):
Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals

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).

Clinical Details

Official title: A Multi-Center, Randomized, Open-Label, Parallel Group Study of FE 999913 Vaginal Tablet 100 mg in Japanese Female Patients Undergoing Fertility Treatment [In Vitro Fertilization/Embryo Transfer (IVF-ET)]

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

The Proportion of Subjects With Blood Progesterone Concentration Not Less Than 10 ng/ml

Ongoing Pregnancy Rate

Secondary outcome:

Rate of Positive βeta Human Chorionic Gonadotrophin (βhCG)

Clinical Pregnancy Rate

Blood Progesterone Concentration

Eligibility

Minimum age: 20 Years. Maximum age: 42 Years. Gender(s): Female.

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 <100 pg/mL.

- Luteinizing hormone (LH), prolactin (PRL), and thyroid-stimulating hormone (TSH),

within the normal limits for the clinical laboratory tests, or considered not clinically significant by the investigator within 6 months prior to screening.

- Documented history of infertility [e. g., unable to conceive for at least one year (or

for 6 months for women ≥38 years of age) or bilateral tubal occlusion or absence].

- Transvaginal ultrasound at screening (or within 14 days prior to screening)

consistent with findings adequate for Assisted Reproduction Technology (ART) with respect to uterus and adnexa (peripheral reproductive organs).

- At least one cycle with no fertility medication prior to screening.

- Hysterosalpingography, hysteroscopy, sonohysterogram, or transvaginal ultrasound

documenting a normal uterine cavity.

- Consent to contraception during the cycle in which pituitary down regulation is

performed (prior to start of controlled ovarian stimulation).

- Signed informed consent to fertility treatment using FE999913 Vaginal Tablet after

the subject and her husband have thoroughly understood the content. Exclusion Criteria:

- Donor oocyte or embryo recipient; gestational or surrogate carrier.

- Undergoing blastomer biopsy and other experimental ART procedures.

- Severe hepatic dysfunction or disease.

- Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of

these events.

- Porphyria.

- Presence of any clinically relevant systemic disease (eg, insulin-dependent diabetes

mellitus).

- Past or current surgical or medical condition which in the judgment of the Principal

Investigator (or Sub-investigator) may interfere with absorption, distribution, metabolism, or excretion of the study drug.

- Subjects with a body mass index (BMI) of >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.

Locations and Contacts

IVF Namba Clinic, Osaka, Japan

Sanno Hospital, Tokyo, Japan

Hanabusa Women's Clinic, Kobe, Hyogo, Japan

Ebina Ladies Clinic, Ebina, Kanagawa, Japan

Sophia Ladies Clinic, Sagamihara, Kanagawa, Japan

Bashamichi Ladies Clinic, Yokohama, Kanagawa, Japan

Additional Information

Starting date: October 2012
Last updated: August 29, 2014

Page last updated: August 23, 2015

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