Trial Outcomes & Findings for A Phase III Study of FE 999913 in Japanese Female Patients Undergoing Fertility Treatment (NCT NCT01710514)
NCT ID: NCT01710514
Last Updated: 2014-09-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
108 participants
Primary outcome timeframe
Day 5 of treatment
Results posted on
2014-09-05
Participant Flow
Participant milestones
| Measure |
FE 999913 100 mg BID
FE 999913 100 mg vaginal tablet BID
FE 999913 vaginal tablet
|
FE 999913 100 mg TID
FE 999913 100 mg vaginal tablet TID
FE 999913 vaginal tablet
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
54
|
|
Overall Study
Intent-To-Treat (ITT) Analysis Set
|
54
|
54
|
|
Overall Study
Full Analysis Set (FAS)
|
46
|
48
|
|
Overall Study
FAS With Embryo Transfer (ET)
|
43
|
47
|
|
Overall Study
Safety Analysis Set
|
54
|
54
|
|
Overall Study
COMPLETED
|
47
|
47
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
FE 999913 100 mg BID
FE 999913 100 mg vaginal tablet BID
FE 999913 vaginal tablet
|
FE 999913 100 mg TID
FE 999913 100 mg vaginal tablet TID
FE 999913 vaginal tablet
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Phase III Study of FE 999913 in Japanese Female Patients Undergoing Fertility Treatment
Baseline characteristics by cohort
| Measure |
FE 999913 100 mg BID
n=46 Participants
FE 999913 100 mg vaginal tablet BID
|
FE 999913 100 mg TID
n=48 Participants
FE 999913 100 mg vaginal tablet TID
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.9 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
34.5 years
STANDARD_DEVIATION 4.25 • n=7 Participants
|
34.7 years
STANDARD_DEVIATION 3.93 • n=5 Participants
|
|
Age, Customized
<35 years
|
17 participants
n=5 Participants
|
21 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Age, Customized
35-37 years
|
17 participants
n=5 Participants
|
14 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Age, Customized
38-40 years
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Age, Customized
41-42 years
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
46 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Day of transfer
Day 3
|
38 participants
n=5 Participants
|
45 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Day of transfer
Day 5
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Subjects with embryo transferred
1 embryo
|
39 participants
n=5 Participants
|
42 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Subjects with embryo transferred
2 embryos
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Embryos transferred
|
1.09 embryos
STANDARD_DEVIATION 0.294 • n=5 Participants
|
1.11 embryos
STANDARD_DEVIATION 0.312 • n=7 Participants
|
1.1 embryos
STANDARD_DEVIATION 0.302 • n=5 Participants
|
|
Method of insemination
IVF
|
19 participants
n=5 Participants
|
21 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Method of insemination
Intracytoplasmic Sperm Injection (ICSI)
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 5 of treatmentPopulation: FAS population
Outcome measures
| Measure |
FE999913 000072 (BID/TID)
n=94 Participants
Data pooled from both BID and TID groups
|
FE 999913 100 mg TID
FE 999913 100 mg vaginal tablet TID
|
FE 999913 Total
Data pooled from BID and TID groups
|
|---|---|---|---|
|
The Proportion of Subjects With Blood Progesterone Concentration Not Less Than 10 ng/ml
|
98.9 percentage of subjects
Interval 94.2 to 100.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 5 of studyPopulation: FAS with ET population
Defined as identification of fetal survival and fetal heart movements on transvaginal ultrasound
Outcome measures
| Measure |
FE999913 000072 (BID/TID)
n=43 Participants
Data pooled from both BID and TID groups
|
FE 999913 100 mg TID
n=47 Participants
FE 999913 100 mg vaginal tablet TID
|
FE 999913 Total
n=90 Participants
Data pooled from BID and TID groups
|
|---|---|---|---|
|
Ongoing Pregnancy Rate
|
14.0 percentage of participants
Interval 5.3 to 27.9
|
29.8 percentage of participants
Interval 17.3 to 44.9
|
22.2 percentage of participants
Interval 14.1 to 32.2
|
SECONDARY outcome
Timeframe: Week 2 of studyPopulation: FAS with ET population In the TID group 13 subjects had a positive beta-hCG assessment while 14 subjects had a positive clinical pregnancy at Week 4. This is because one subject had a negative beta-hCG at Week 2, but she had a positive local serum hCG on the same day and continued the trial. Then clinical and ongoing pregnancy were confirmed.
Outcome measures
| Measure |
FE999913 000072 (BID/TID)
n=43 Participants
Data pooled from both BID and TID groups
|
FE 999913 100 mg TID
n=47 Participants
FE 999913 100 mg vaginal tablet TID
|
FE 999913 Total
n=90 Participants
Data pooled from BID and TID groups
|
|---|---|---|---|
|
Rate of Positive βeta Human Chorionic Gonadotrophin (βhCG)
|
16.3 percentage of participants
Interval 6.8 to 30.7
|
27.7 percentage of participants
Interval 15.6 to 42.6
|
22.2 percentage of participants
Interval 14.1 to 32.2
|
SECONDARY outcome
Timeframe: Week 4 of studyPopulation: FAS with ET population
Defined as presence of a gestational sac on transvaginal ultrasound
Outcome measures
| Measure |
FE999913 000072 (BID/TID)
n=43 Participants
Data pooled from both BID and TID groups
|
FE 999913 100 mg TID
n=47 Participants
FE 999913 100 mg vaginal tablet TID
|
FE 999913 Total
n=90 Participants
Data pooled from BID and TID groups
|
|---|---|---|---|
|
Clinical Pregnancy Rate
|
14.0 percentage of participants
Interval 5.3 to 27.9
|
29.8 percentage of participants
Interval 17.3 to 44.9
|
22.2 percentage of participants
Interval 14.1 to 32.2
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 5, 8, and end of studyPopulation: FAS population
Outcome measures
| Measure |
FE999913 000072 (BID/TID)
n=46 Participants
Data pooled from both BID and TID groups
|
FE 999913 100 mg TID
n=48 Participants
FE 999913 100 mg vaginal tablet TID
|
FE 999913 Total
n=94 Participants
Data pooled from BID and TID groups
|
|---|---|---|---|
|
Blood Progesterone Concentration
Week 4; n=6, 14, 20
|
32.5 ng/mL
Standard Deviation 23.1
|
77.9 ng/mL
Standard Deviation 41.3
|
64.2 ng/mL
Standard Deviation 42.0
|
|
Blood Progesterone Concentration
Week 5; n=6, 14,20
|
32.3 ng/mL
Standard Deviation 17.0
|
67.7 ng/mL
Standard Deviation 35.7
|
57.1 ng/mL
Standard Deviation 35.0
|
|
Blood Progesterone Concentration
Baseline; n=46, 48, 94
|
0.626 ng/mL
Standard Deviation 0.379
|
0.704 ng/mL
Standard Deviation 0.364
|
0.666 ng/mL
Standard Deviation 0.371
|
|
Blood Progesterone Concentration
Week 2; n=32, 42,74
|
11.4 ng/mL
Standard Deviation 12.0
|
30.7 ng/mL
Standard Deviation 37.9
|
22.3 ng/mL
Standard Deviation 31.0
|
|
Blood Progesterone Concentration
Week 8; n=5, 12, 17
|
41.4 ng/mL
Standard Deviation 15.7
|
53.3 ng/mL
Standard Deviation 23.5
|
49.8 ng/mL
Standard Deviation 21.7
|
|
Blood Progesterone Concentration
End of study; n=38, 46, 84
|
10.8 ng/mL
Standard Deviation 16.3
|
21.9 ng/mL
Standard Deviation 26.4
|
16.9 ng/mL
Standard Deviation 23.0
|
Adverse Events
FE 999913 100 mg BID
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
FE 999913 100 mg TID
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
FE 999913 Total
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FE 999913 100 mg BID
n=54 participants at risk
FE 999913 100 mg vaginal tablet BID
|
FE 999913 100 mg TID
n=54 participants at risk
FE 999913 100 mg vaginal tablet TID
|
FE 999913 Total
n=108 participants at risk
Data pooled from BID and TID groups
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Subchorionic haemorrhage
|
0.00%
0/54
|
1.9%
1/54 • Number of events 1
|
0.93%
1/108 • Number of events 1
|
Other adverse events
| Measure |
FE 999913 100 mg BID
n=54 participants at risk
FE 999913 100 mg vaginal tablet BID
|
FE 999913 100 mg TID
n=54 participants at risk
FE 999913 100 mg vaginal tablet TID
|
FE 999913 Total
n=108 participants at risk
Data pooled from BID and TID groups
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
1.9%
1/54 • Number of events 1
|
5.6%
3/54 • Number of events 3
|
3.7%
4/108 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/54
|
5.6%
3/54 • Number of events 3
|
2.8%
3/108 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.7%
2/54 • Number of events 2
|
0.00%
0/54
|
1.9%
2/108 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
1.9%
1/54 • Number of events 1
|
3.7%
2/54 • Number of events 2
|
2.8%
3/108 • Number of events 3
|
|
Nervous system disorders
Headache
|
0.00%
0/54
|
3.7%
2/54 • Number of events 4
|
1.9%
2/108 • Number of events 4
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
18.5%
10/54 • Number of events 10
|
22.2%
12/54 • Number of events 12
|
20.4%
22/108 • Number of events 22
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
1.9%
1/54 • Number of events 1
|
5.6%
3/54 • Number of events 3
|
3.7%
4/108 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/54
|
1.9%
1/54 • Number of events 1
|
0.93%
1/108 • Number of events 1
|
|
Investigations
Liver function test abnormal
|
1.9%
1/54 • Number of events 1
|
0.00%
0/54
|
0.93%
1/108 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/54
|
1.9%
1/54 • Number of events 1
|
0.93%
1/108 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
1.9%
1/54 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
1.9%
2/108 • Number of events 2
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/54
|
1.9%
1/54 • Number of events 1
|
0.93%
1/108 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.00%
0/54
|
1.9%
1/54 • Number of events 1
|
0.93%
1/108 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/54
|
1.9%
1/54 • Number of events 1
|
0.93%
1/108 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
- Publication restrictions are in place
Restriction type: OTHER