Luteal Hormone SupplementationPhase 3NCT01710514

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

A Phase 3 study testing FE 999913 vaginal tablet in people with Luteal Hormone Supplementation, run by Ferring Pharmaceuticals at 6 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 20 to 42 years, women only
Conditions the study is for: Luteal Hormone Supplementation
What is being tested?: FE 999913 vaginal tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 6 sitesJapan
Study dates: Oct 2012to Aug 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 42 years
Women only
No healthy volunteers
Adult

Who may be able to join

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.

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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.

Who cannot join

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).

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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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Japan6 sites

Ebina Ladies Clinic
Ebina, Kanagawa
Hanabusa Women's Clinic
Kobe, Hyōgo
IVF Namba Clinic
Osaka, Osaka
Sophia Ladies Clinic
Sagamihara, Kanagawa
Sanno Hospital
Tokyo
Bashamichi Ladies Clinic
Yokohama, Kanagawa

Other trials in Japan

About this study

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)]

Conditions: Luteal Hormone Supplementation
Being tested: FE 999913 vaginal tablet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FE 999913 vaginal tabletDrug

Study groups in NCT01710514
Study group	Role	What they receive
FE 999913 100 mg BID	Active comparator	FE 999913 100 mg vaginal tablet BID Receives: Drug: FE 999913 vaginal tablet
FE 999913 100 mg TID	Active comparator	FE 999913 100 mg vaginal tablet TID Receives: Drug: FE 999913 vaginal tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Aug 2013

First posted19 Oct 2012 (estimated)
Study startOct 2012
Primary completionAug 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Luteal Hormone SupplementationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01710514
Sponsor's protocol ID: 000072
Status last verified: Aug 2014
First submitted: 9 Oct 2012
Last updated: 5 Sep 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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. doi: 10.1007/s12522-015-0211-y. Epub 2015 Jun 14.
PubMed 26457065

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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)]
ClinicalTrials.gov ID: NCT01710514
Acronym / sponsor ID: 000072
Conditions: Luteal Hormone Supplementation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 19 Oct 2012 (estimated)
Results: Posted 19 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
FE 999913 100 mg BID	Active comparator	Drug: FE 999913 vaginal tabletFE 999913 100 mg vaginal tablet BID
FE 999913 100 mg TID	Active comparator	Drug: FE 999913 vaginal tabletFE 999913 100 mg vaginal tablet TID

Who may qualify

Ages: 20 to 42 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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).

Key exclusion criteria (20 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FE 999913 vaginal tablet	Drug	FE 999913 100 mg BID, FE 999913 100 mg TID

Primary outcome

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

3 secondary outcomes

Rate of Positive βeta Human Chorionic Gonadotrophin (βhCG)
Time frame: Week 2 of study
Clinical Pregnancy Rate
Time frame: Week 4 of study
Blood Progesterone Concentration
Time frame: Weeks 2, 4, 5, 8, and end of study

Results and safety

Results posted to the registry on 19 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FE 999913 100 mg BID	54	47
FE 999913 100 mg TID	54	47

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

Time frame: Day 5 of treatment. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	FE999913 000072 (BID/TID) n = 94
Value	98.9 (94.2 to 100.0)

FE999913 000072 (BID/TID): Difference of % to historical control: -0.9 (95% CI -3.6 to 1.8)

Population analysed: FAS population

Primary outcome: Ongoing Pregnancy Rate

Time frame: Week 5 of study. Number (95% Confidence Interval). Unit: percentage of participants

Measure	FE 999913 100 mg BID n = 43	FE 999913 100 mg TID n = 47	FE 999913 Total n = 90
Value	14.0 (5.3 to 27.9)	29.8 (17.3 to 44.9)	22.2 (14.1 to 32.2)

Population analysed: FAS with ET population

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FE 999913 100 mg BID	0 of 54 (0%)	15 of 54 (27.8%)	Not reported
FE 999913 100 mg TID	1 of 54 (1.9%)	22 of 54 (40.7%)	Not reported
FE 999913 Total	1 of 108 (0.9%)	37 of 108 (34.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26457065Fujiwara 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. doi: 10.1007/s12522-015-0211-y. Epub 2015 Jun 14.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Development Support study director

Ferring Pharmaceuticals

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FE 999913 vaginal tablet in people with Luteal Hormone Supplementation, run by Ferring Pharmaceuticals at 6 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Proportion of Subjects With Blood Progesterone Concentration Not Less Than 10 ng/ml (time frame: Day 5 of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01710514, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2014.