Percentage of Participants With Ovulation
| Group | Value (Percentage of participants) |
|---|---|
| AS900672-Enriched 10 Mcg | 46.2 |
| AS900672-Enriched 20 Mcg | 46.2 |
| AS900672-Enriched 30 Mcg | 38.5 |
| AS900672-Enriched 40 Mcg | 33.3 |
| Follitropin Alfa 75 IU | 53.8 |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataThis trial was stopped early.
Reason given at the registry: The study was terminated after Merck Serono had taken the decision not to pursue the development of AS900672-enriched in ovulation induction
Results were posted for this trial.
Switzerland
1 trial · 1 stopped early · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a Phase 2, interventional, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in oligo-anovulatory women undergoing ovulation induction (OI). This study will compare 4 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f ®) prefilled pen with regards to ovulation rate.
Experimental
AS900672-Enriched 10 mcg
Experimental
AS900672-Enriched 20 mcg
Experimental
AS900672-Enriched 30 mcg
Experimental
AS900672-Enriched 40 mcg
Active comparator
Follitropin alfa 75 IU
Outcomes the sponsor listed as primary.
Percentage of Participants With Ovulation
Time frame · Mid-luteal phase progesterone assessed 5-10 days or clinical pregnancy 35-42 days after recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 14 days])
Ovulation was defined as a mid-luteal phase progesterone (P4) level \>= 30 nanomole per liter (nmol/L) (10 nanogram per milliliter \[ng/mL\]). In the absence of a positive progesterone response, clinical pregnancy was also considered as evidence of ovulation.
Percentage of Participants With Clinical Pregnancy
Time frame · Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
Clinical pregnancy was defined as the presence of one or more fetal sacs with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.
Duration of Ovarian Stimulation
Time frame · Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])
Ovarian stimulation included from first dose of study drug on S1 until day on which r-hCG was administered (r-hCG day).
Duration of Supplemental Follitropin Alfa Treatment
Time frame · Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])
Cumulative Dose of Supplemental Follitropin Alfa Administered
Time frame · Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])
Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm
Time frame · Stimulation Day 5 (S5), S7 and r-hCG administration day (end of stimulation cycle [approximately 14 days])
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Percentage of participants) |
|---|---|
| AS900672-Enriched 10 Mcg | 46.2 |
| AS900672-Enriched 20 Mcg | 46.2 |
| AS900672-Enriched 30 Mcg | 38.5 |
| AS900672-Enriched 40 Mcg | 33.3 |
| Follitropin Alfa 75 IU | 53.8 |
| Group | Value (Percentage of participants) |
|---|---|
| AS900672-Enriched 10 Mcg | 23.1 |
| AS900672-Enriched 20 Mcg | 0.0 |
| AS900672-Enriched 30 Mcg | 7.7 |
| AS900672-Enriched 40 Mcg | 16.7 |
| Follitropin Alfa 75 IU | 0.0 |
| Group | Value (Days) | Spread |
|---|---|---|
| AS900672-Enriched 10 Mcg | 10.0 | 5.3 |
| AS900672-Enriched 20 Mcg | 11.8 | 3.4 |
| AS900672-Enriched 30 Mcg | 14.0 | 1.4 |
| AS900672-Enriched 40 Mcg | 10.8 | 3.7 |
| Follitropin Alfa 75 IU | 10.6 | 3.2 |
| Group | Value (Days) | Spread |
|---|---|---|
| AS900672-Enriched 10 Mcg | 6.6 | 1.4 |
| AS900672-Enriched 20 Mcg | 6.6 | 1.4 |
| AS900672-Enriched 30 Mcg | 7.7 | 1.5 |
| AS900672-Enriched 40 Mcg | 5.6 | 2.2 |
| Follitropin Alfa 75 IU | 5.5 | 2.7 |
| Group | Value (IU) | Spread |
|---|---|---|
| AS900672-Enriched 10 Mcg | 476.3 | 122.5 |
| AS900672-Enriched 20 Mcg | 493.8 | 108.3 |
| AS900672-Enriched 30 Mcg | 556.7 | 134.2 |
| AS900672-Enriched 40 Mcg | 398.9 | 167.9 |
| Follitropin Alfa 75 IU | 397.5 | 226.5 |
| Group | Value (Follicles) | Spread |
|---|---|---|
| AS900672-Enriched 10 Mcg | 23.6 | 13.8 |
| AS900672-Enriched 20 Mcg | 28.7 | 29.4 |
| AS900672-Enriched 30 Mcg | 23.2 | 6.7 |
| AS900672-Enriched 40 Mcg | 20.9 | 16.7 |
| Follitropin Alfa 75 IU | 21.3 | 13.7 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| AS900672-Enriched 10 McgSingle injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to \[=\<\] 3 follicles with a mean diameter of greater than or equal to \[\>=\] 14 millimeter \[mm\], and one or two of these follicles with a diameter of \>= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days. | – | 0 / 14 | 7 / 14 |
| AS900672-Enriched 20 McgSingle injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days. | – | 0 / 14 | 3 / 14 |
| AS900672-Enriched 30 McgSingle injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days. | – | 0 / 15 | 6 / 15 |
| AS900672-Enriched 40 McgSingle injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days. | – | 0 / 13 | 4 / 13 |
| Follitropin Alfa 75 IUFollitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days. | – | 0 / 15 | 7 / 15 |
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