Trial Outcomes & Findings for A Trial to Compare Efficacy and Safety of Follitropin Delta Versus Placebo (Inactive Treatment) in the Treatment of Men With Idiopathic Infertility (Unexplained Reduction of Semen Quality) (ADAM) (NCT NCT05403476)
NCT ID: NCT05403476
Last Updated: 2026-08-28
Results Overview
Vital pregnancy is documentation of at least one intrauterine gestational sac with fetal heartbeat by ultrasound.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Up to 9 months after randomization
Results posted on
2026-08-28
Participant Flow
Only male participants were enrolled in the study, and not their female partners. Enrollment information consists of only males that were exposed to FE 999049 or placebo, and does not represent dyads - please see gender baseline characteristics. Female partners were only analysed for pregnancy and not enrolled in this study.
Participant milestones
| Measure |
FE 999049 (Follitropin Delta)
FE 999049: FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.
|
Placebo
Placebo: Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
|
Overall Study
COMPLETED
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial to Compare Efficacy and Safety of Follitropin Delta Versus Placebo (Inactive Treatment) in the Treatment of Men With Idiopathic Infertility (Unexplained Reduction of Semen Quality) (ADAM)
Baseline characteristics by cohort
| Measure |
FE 999049 (Follitropin Delta)
n=1 Participants
FE 999049: FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.
|
Placebo
n=3 Participants
Placebo: Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
White
|
1 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
4 Participants
n=80 Participants
|
|
Age, Customized
18 - 50 years
|
1 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
4 Participants
n=80 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
4 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: Up to 9 months after randomizationVital pregnancy is documentation of at least one intrauterine gestational sac with fetal heartbeat by ultrasound.
Outcome measures
| Measure |
FE 999049 (Follitropin Delta)
n=1 Participants
FE 999049: FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.
|
Placebo
n=3 Participants
Placebo: Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.
|
|---|---|---|
|
Spontaneous Pregnancy Observed in Female Partner Within 9 Months After Randomization of Male Subject, Where Spontaneous Pregnancy is Defined as Vital Pregnancy
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 9 months (End-of-Trial)Outcome measures
| Measure |
FE 999049 (Follitropin Delta)
n=1 Participants
FE 999049: FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.
|
Placebo
n=3 Participants
Placebo: Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.
|
|---|---|---|
|
Positive Beta-Human Chorionic Gonadotropins (βhCG) (Positive Urine βhCG Test) Observed in Female Partner
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: The partner that achieved spontaneous pregnancy was outside the time frame.
Outcome measures
| Measure |
FE 999049 (Follitropin Delta)
FE 999049: FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.
|
Placebo
n=1 Participants
Placebo: Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.
|
|---|---|---|
|
Time From Randomization to Spontaneous Pregnancy Observed in Female Partner.
|
—
|
NA Days
The partner that achieved spontaneous pregnancy was outside the time frame.
|
SECONDARY outcome
Timeframe: From pre-randomisation to end of trial (9 months)Change from baseline pre-randomisation to end of trial, which is 9 months.
Outcome measures
| Measure |
FE 999049 (Follitropin Delta)
n=1 Participants
FE 999049: FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.
|
Placebo
n=3 Participants
Placebo: Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.
|
|---|---|---|
|
Changes in Semen Volume From Pre-randomisation to 9 Months After Randomization
|
0.5 mL
Interval 0.5 to 0.5
|
-1.25 mL
Interval -2.5 to 0.95
|
SECONDARY outcome
Timeframe: From pre-randomization to end of trial (9 months)Change from baseline from pre-randomisation to end of trial, which is 9 months
Outcome measures
| Measure |
FE 999049 (Follitropin Delta)
n=1 Participants
FE 999049: FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.
|
Placebo
n=3 Participants
Placebo: Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.
|
|---|---|---|
|
Changes in Sperm Concentration
|
-2.14 x10^6 sperm/mL
Interval -2.14 to -2.14
|
-0.7 x10^6 sperm/mL
Interval -1.2 to 2.0
|
SECONDARY outcome
Timeframe: From pre-randomisation to end of trial (9 months)Change from baseline from pre-randomisation to end of trial, which is 9 months
Outcome measures
| Measure |
FE 999049 (Follitropin Delta)
n=1 Participants
FE 999049: FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.
|
Placebo
n=3 Participants
Placebo: Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.
|
|---|---|---|
|
Changes in Total Sperm Count
|
-13.01 x10^6 sperm
Interval -13.01 to -13.01
|
-3.75 x10^6 sperm
Interval -15.9 to -0.75
|
SECONDARY outcome
Timeframe: From pre-randomisation to end of trial (9 months)Change from baseline from pre-randomisation to end of trial, which is 9 months
Outcome measures
| Measure |
FE 999049 (Follitropin Delta)
n=1 Participants
FE 999049: FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.
|
Placebo
n=3 Participants
Placebo: Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.
|
|---|---|---|
|
Changes in Total Motile Sperm Count
|
-3.74 x10^6 sperm
Interval -3.74 to -3.74
|
-0.965 x10^6 sperm
Interval -3.71 to 0.24
|
SECONDARY outcome
Timeframe: From pre-randomisation to end of trial (up to 9 months)Population: No data was collected for the participant in the FE 999049 arm following the pre-randomisation visit.
Change from baseline from pre-randomisation to end of trial, which is 9 months
Outcome measures
| Measure |
FE 999049 (Follitropin Delta)
FE 999049: FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.
|
Placebo
n=3 Participants
Placebo: Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.
|
|---|---|---|
|
Changes in Sperm Morphology
|
—
|
0.0 % of sperm with normal shape
Interval -2.0 to 5.0
|
SECONDARY outcome
Timeframe: From pre-randomization to end of treatmentPopulation: Due to early termination of the trial, samples that were collected for this measure were neither processed nor analysed for DNA fragmentation, for any subject.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 6 and 9 monthsOutcome measures
| Measure |
FE 999049 (Follitropin Delta)
n=1 Participants
FE 999049: FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.
|
Placebo
n=3 Participants
Placebo: Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.
|
|---|---|---|
|
Treatment Responders Defined by Either Spontaneous Pregnancy Observed in Female Partner, or Increase of Total Sperm Count or Total Motile Sperm Count to 50% Over Average Baseline at 6 and/or 9 Months
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From randomization to 6 months after randomizationChange from baseline.
Outcome measures
| Measure |
FE 999049 (Follitropin Delta)
n=1 Participants
FE 999049: FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.
|
Placebo
n=3 Participants
Placebo: Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.
|
|---|---|---|
|
Changes in Follicle Stimulating Hormone (FSH)
|
2.10 IU/L
Interval 2.1 to 2.1
|
0.10 IU/L
Interval -0.5 to 2.3
|
SECONDARY outcome
Timeframe: From randomisation to 3 and 6 months after randomizationFrom randomisation to 3 and 6 months
Outcome measures
| Measure |
FE 999049 (Follitropin Delta)
n=1 Participants
FE 999049: FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.
|
Placebo
n=3 Participants
Placebo: Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.
|
|---|---|---|
|
Changes in Luteinising Hormone (LH)
3 months
|
-0.76 IU/L
Interval -0.76 to -0.76
|
-0.46 IU/L
Interval -0.61 to -0.22
|
|
Changes in Luteinising Hormone (LH)
6 months
|
1.23 IU/L
Interval 1.23 to 1.23
|
0.28 IU/L
Interval -0.37 to 1.85
|
SECONDARY outcome
Timeframe: From randomization to 6 months after randomizationChange from baseline.
Outcome measures
| Measure |
FE 999049 (Follitropin Delta)
n=1 Participants
FE 999049: FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.
|
Placebo
n=3 Participants
Placebo: Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.
|
|---|---|---|
|
Changes in Inhibin B
|
28.0 pg/mL
Interval 28.0 to 28.0
|
-4.0 pg/mL
Interval -19.0 to 16.0
|
SECONDARY outcome
Timeframe: From randomization to 6 months after randomizationChange from baseline.
Outcome measures
| Measure |
FE 999049 (Follitropin Delta)
n=1 Participants
FE 999049: FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.
|
Placebo
n=3 Participants
Placebo: Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.
|
|---|---|---|
|
Changes in Testosterone
|
6.25 nmol/L
Interval 6.25 to 6.25
|
-0.35 nmol/L
Interval -2.43 to 4.85
|
SECONDARY outcome
Timeframe: From randomization to 6 months after randomizationChange from baseline.
Outcome measures
| Measure |
FE 999049 (Follitropin Delta)
n=1 Participants
FE 999049: FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.
|
Placebo
n=3 Participants
Placebo: Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.
|
|---|---|---|
|
Changes in Estradiol
|
47.5 pmol/L
Interval 47.5 to 47.5
|
33.0 pmol/L
Interval 0.0 to 69.0
|
SECONDARY outcome
Timeframe: From randomization to 6 months after randomizationBlood samples for assessment of sex hormone binding globulin (SHBG) concentrations will be drawn in order to calculate change from baseline in free testosterone concentrations.
Outcome measures
| Measure |
FE 999049 (Follitropin Delta)
n=1 Participants
FE 999049: FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.
|
Placebo
n=3 Participants
Placebo: Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.
|
|---|---|---|
|
Changes in Free Testosterone Concentration
|
6.25 nmol/L
Interval 6.25 to 6.25
|
-0.35 nmol/L
Interval -2.43 to 4.85
|
SECONDARY outcome
Timeframe: From randomization to 21-35 days after End-of-treatment (9 months)Blood samples for assessment of anti-FSH antibodies will be drawn.
Outcome measures
| Measure |
FE 999049 (Follitropin Delta)
n=1 Participants
FE 999049: FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.
|
Placebo
n=3 Participants
Placebo: Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.
|
|---|---|---|
|
Number of Participants With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralising Capacity
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From randomization to End-of-Trial (up to 9 months)All treatment-emergent adverse events will be analyzed to identify those that potentially are immune related.
Outcome measures
| Measure |
FE 999049 (Follitropin Delta)
n=1 Participants
FE 999049: FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.
|
Placebo
n=3 Participants
Placebo: Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.
|
|---|---|---|
|
Number of Participants With Immune-related Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
FE 999049 (Follitropin Delta)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Global Clinical Compliance
Ferring Pharmceuticals A/S
Phone: 1-888-337-7464
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is the sponsor can review results communications before public release and can prohibit communications about trial results \_for less than or equal to 60 days\_ from the time submitted to the sponsor for review. Longer time may be needed to allow the sponsor to seek patent protection. The PI must not present or publish results until 18 months after database lock unless a) the sponsor has already published the results or b) sponsor's permission is obtained.
- Publication restrictions are in place
Restriction type: OTHER