Trial Outcomes & Findings for Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix (NCT NCT00434122)
NCT ID: NCT00434122
Last Updated: 2011-06-02
Results Overview
Explanation of the term "coefficient of variation": The coefficient of variation is a normalized measure of dispersion of a probability distribution.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
85 participants
Primary outcome timeframe
Stimulation Day 1
Results posted on
2011-06-02
Participant Flow
Participant milestones
| Measure |
Degarelix Mid-luteal, 2.5 mg
Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
|
Placebo
Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.
or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
43
|
|
Overall Study
Intention-to-treat (ITT) Population
|
39
|
39
|
|
Overall Study
COMPLETED
|
36
|
36
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
Degarelix Mid-luteal, 2.5 mg
Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
|
Placebo
Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.
or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
|
|---|---|---|
|
Overall Study
Non-compliance with protocol
|
0
|
1
|
|
Overall Study
loss of subject contact
|
1
|
1
|
|
Overall Study
Personal reasons
|
1
|
1
|
|
Overall Study
Large follicle size
|
2
|
2
|
|
Overall Study
Low follicular response.
|
1
|
2
|
|
Overall Study
Travelling of subject.
|
1
|
0
|
Baseline Characteristics
Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix
Baseline characteristics by cohort
| Measure |
Degarelix Mid-luteal, 2.5 mg
n=39 Participants
Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
|
Placebo
n=39 Participants
Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.
or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=39 Participants
|
39 Participants
n=41 Participants
|
78 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age Continuous
|
28.9 years
STANDARD_DEVIATION 4.1 • n=39 Participants
|
28.0 years
STANDARD_DEVIATION 3.9 • n=41 Participants
|
28.4 years
STANDARD_DEVIATION 4.0 • n=35 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=39 Participants
|
39 Participants
n=41 Participants
|
78 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
Czech Republic
|
7 participants
n=39 Participants
|
7 participants
n=41 Participants
|
14 participants
n=35 Participants
|
|
Region of Enrollment
Spain
|
27 participants
n=39 Participants
|
26 participants
n=41 Participants
|
53 participants
n=35 Participants
|
|
Region of Enrollment
Belgium
|
5 participants
n=39 Participants
|
6 participants
n=41 Participants
|
11 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Stimulation Day 1Explanation of the term "coefficient of variation": The coefficient of variation is a normalized measure of dispersion of a probability distribution.
Outcome measures
| Measure |
Degarelix Mid-luteal, 2.5 mg
n=39 Participants
Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
|
Placebo
n=39 Participants
Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.
or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
|
Ganirelix, 0.25 mg
Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
|
|---|---|---|---|
|
Coefficient of Variation of Follicular Sizes on Stimulation Day 1 (Follicles ≥ 2 mm)
|
36.7 Percentage
Standard Deviation 5.6
|
39.2 Percentage
Standard Deviation 9.5
|
—
|
SECONDARY outcome
Timeframe: 7 days after hCG injectionPopulation: Subjects with evaluable endometrial biopsies 7 days after injection with hCG.
An adequate secretory endometrium 7 days after hCG injection was defined as secretory in the histological classification and with endometrial dating corresponding to the expected cycle day ±1 day.
Outcome measures
| Measure |
Degarelix Mid-luteal, 2.5 mg
n=32 Participants
Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
|
Placebo
n=14 Participants
Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.
or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
|
Ganirelix, 0.25 mg
n=16 Participants
Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
|
|---|---|---|---|
|
Frequency of Oocyte Donors With Adequate Secretory Transformation at the Endometrial Histology Evaluation 7 Days After Injection With Human Chorionic Gonadotrophin (hCG)
|
31 Participants
|
11 Participants
|
14 Participants
|
Adverse Events
Degarelix, 2.5 mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Ganirelix, 0.25 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Degarelix, 2.5 mg
n=63 participants at risk
Combination of these two groups: Degarelix Mid-luteal 2.5 mg and Degarelix Follicular 2.5 mg.
Degarelix Mid-luteal, 2.5 mg: Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
Degarelix Follicular, 2.5 mg: Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.
|
Ganirelix, 0.25 mg
n=22 participants at risk
Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
1.6%
1/63 • Number of events 1 • From signed informed consent till end-of-trial visit (approximately 12 +/- 2 weeks after oocyte retrieval)
Evaluated at each trial visit
|
0.00%
0/22 • From signed informed consent till end-of-trial visit (approximately 12 +/- 2 weeks after oocyte retrieval)
Evaluated at each trial visit
|
Other adverse events
| Measure |
Degarelix, 2.5 mg
n=63 participants at risk
Combination of these two groups: Degarelix Mid-luteal 2.5 mg and Degarelix Follicular 2.5 mg.
Degarelix Mid-luteal, 2.5 mg: Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
Degarelix Follicular, 2.5 mg: Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.
|
Ganirelix, 0.25 mg
n=22 participants at risk
Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
|
|---|---|---|
|
General disorders
Injection site erythema
|
4.8%
3/63 • Number of events 3 • From signed informed consent till end-of-trial visit (approximately 12 +/- 2 weeks after oocyte retrieval)
Evaluated at each trial visit
|
0.00%
0/22 • From signed informed consent till end-of-trial visit (approximately 12 +/- 2 weeks after oocyte retrieval)
Evaluated at each trial visit
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/63 • From signed informed consent till end-of-trial visit (approximately 12 +/- 2 weeks after oocyte retrieval)
Evaluated at each trial visit
|
4.5%
1/22 • Number of events 1 • From signed informed consent till end-of-trial visit (approximately 12 +/- 2 weeks after oocyte retrieval)
Evaluated at each trial visit
|
|
Psychiatric disorders
Mood swings
|
4.8%
3/63 • Number of events 3 • From signed informed consent till end-of-trial visit (approximately 12 +/- 2 weeks after oocyte retrieval)
Evaluated at each trial visit
|
0.00%
0/22 • From signed informed consent till end-of-trial visit (approximately 12 +/- 2 weeks after oocyte retrieval)
Evaluated at each trial visit
|
|
Reproductive system and breast disorders
Menstruation delayed
|
1.6%
1/63 • Number of events 1 • From signed informed consent till end-of-trial visit (approximately 12 +/- 2 weeks after oocyte retrieval)
Evaluated at each trial visit
|
9.1%
2/22 • Number of events 2 • From signed informed consent till end-of-trial visit (approximately 12 +/- 2 weeks after oocyte retrieval)
Evaluated at each trial visit
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/63 • From signed informed consent till end-of-trial visit (approximately 12 +/- 2 weeks after oocyte retrieval)
Evaluated at each trial visit
|
4.5%
1/22 • Number of events 1 • From signed informed consent till end-of-trial visit (approximately 12 +/- 2 weeks after oocyte retrieval)
Evaluated at each trial visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restiction 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.
- Publication restrictions are in place
Restriction type: OTHER