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

• ClinicalTrials.gov Identifier: NCT01710514
• Recruitment Status: Completed
• First Posted: October 19, 2012
• Results First Posted: August 19, 2014
• Last Update Posted: September 5, 2014
• Sponsor: Ferring Pharmaceuticals
• Information provided by (Responsible Party): Ferring Pharmaceuticals

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Luteal Hormone Supplementation	Drug: FE 999913 vaginal tablet	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: October 2012
• Actual Primary Completion Date: August 2013
• Actual Study Completion Date: August 2013

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: FE 999913 100 mg BID; FE 999913 100 mg vaginal tablet BID	Drug: FE 999913 vaginal tablet
Active Comparator: FE 999913 100 mg TID; FE 999913 100 mg vaginal tablet TID	Drug: FE 999913 vaginal tablet

Outcome Measures

Primary Outcome Measures :

1. The Proportion of Subjects With Blood Progesterone Concentration Not Less Than 10 ng/ml [ Time Frame: Day 5 of treatment ]
2. Ongoing Pregnancy Rate [ Time Frame: Week 5 of study ]
   Defined as identification of fetal survival and fetal heart movements on transvaginal ultrasound

Secondary Outcome Measures :

1. Rate of Positive βeta Human Chorionic Gonadotrophin (βhCG) [ Time Frame: Week 2 of study ]
2. Clinical Pregnancy Rate [ Time Frame: Week 4 of study ]
   Defined as presence of a gestational sac on transvaginal ultrasound
3. Blood Progesterone Concentration [ Time Frame: Weeks 2, 4, 5, 8, and end of study ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 42 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

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

IVF Namba Clinic

Osaka, Japan

Sanno Hospital

Tokyo, Japan

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

• Study Director: Clinical Development Support; Ferring Pharmaceuticals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fujiwara T. A multi-center, randomized, open-label, parallel group study of a natural micronized progesterone vaginal tablet as a luteal support agent in Japanese women undergoing assisted reproductive technology. Reprod Med Biol. 2015;14(4):185-193. Epub 2015 Jun 14.

• Responsible Party: Ferring Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01710514
• Other Study ID Numbers: 000072
• First Posted: October 19, 2012
• Results First Posted: August 19, 2014
• Last Update Posted: September 5, 2014
• Last Verified: August 2014