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The study was terminated after Merck Serono had taken the decision not to pursue the development of AS900672-enriched in ovulation induction
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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.
The study was terminated after Merck Serono had taken the decision not to pursue the development of AS900672-enriched in ovulation induction (OI). This decision was not related to any safety or efficacy concerns over the use of AS900672-Enriched in OI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AS900672-Enriched 10 mcg | Experimental |
| |
| AS900672-Enriched 20 mcg | Experimental |
| |
| AS900672-Enriched 30 mcg | Experimental |
| |
| AS900672-Enriched 40 mcg | Experimental |
| |
| Follitropin alfa 75 IU | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AS900672-Enriched 10 microgram (mcg) | Drug | Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 mcg will be administered subcutaneously on Stimulation Day 1 (S1). Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Ovulation | 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. | 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]) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Pregnancy | 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. | Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days]) |
| Duration of Ovarian Stimulation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Pellicer, Professor Dr | IVI Valencia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merck Serono S.A. | Geneva | 1202 | Switzerland |
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| ID | Title | Description |
|---|---|---|
| FG000 | AS900672-Enriched 10 Mcg | Single 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. |
| FG001 | AS900672-Enriched 20 Mcg | Single 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. |
| FG002 | AS900672-Enriched 30 Mcg | Single 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. |
| FG003 | AS900672-Enriched 40 Mcg | Single 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. |
| FG004 | Follitropin Alfa 75 IU | Follitropin 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AS900672-Enriched 10 Mcg | Single 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Ovulation | 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. | Per Protocol (PP) population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | Number | Percentage of participants | 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]) |
|
Stimulation Day 1 (S1) up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AS900672-Enriched 10 Mcg | Single 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
The study was terminated after Merck Serono had taken the decision not to pursue the development of AS900672-enriched in ovulation induction
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571801 | follitropin alfa |
| D005640 | Follicle Stimulating Hormone |
| D006063 | Chorionic Gonadotropin |
| ID | Term |
|---|---|
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
Not provided
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Not provided
Not provided
Not provided
Not provided
|
|
| AS900672-Enriched 20 mcg | Drug | Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days. |
|
|
| AS900672-Enriched 30 mcg | Drug | Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days. |
|
|
| AS900672-Enriched 40 mcg | Drug | Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days. |
|
|
| Follitropin alfa 75 international unit (IU) | Drug | Follitropin alfa (Gonal-f®) 75 IU will be administered subcutaneously once daily from S1 up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. Subjects who will be receiving AS900672-Enriched 10, 20, 30 and 40 mcg will also receive daily dose of follitropin alfa 75 IU subcutaneously from Stimulation Day 7 (S7) up to S14. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days. |
|
|
| Recombinant human chorionic gonadotropin (r-hCG) | Drug | Recombinant human chorionic gonadotropin (r-hCG) will be administered as a single dose of 250 mcg subcutaneously, when follicular response is 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). |
|
Ovarian stimulation included from first dose of study drug on S1 until day on which r-hCG was administered (r-hCG day). |
| Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle [approximately 14 days]) |
| Duration of Supplemental Follitropin Alfa Treatment | Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days]) |
| Cumulative Dose of Supplemental Follitropin Alfa Administered | 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 | Stimulation Day 5 (S5), S7 and r-hCG administration day (end of stimulation cycle [approximately 14 days]) |
| Lack of ovarian response |
|
| Ovarian hyperstimulation syndrome risk |
|
| Risk of multiple pregnancy |
|
| Other |
|
| BG001 | AS900672-Enriched 20 Mcg | Single 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. |
| BG002 | AS900672-Enriched 30 Mcg | Single 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. |
| BG003 | AS900672-Enriched 40 Mcg | Single 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. |
| BG004 | Follitropin Alfa 75 IU | Follitropin 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. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | AS900672-Enriched 20 Mcg | Single 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. |
| OG002 | AS900672-Enriched 30 Mcg | Single 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. |
| OG003 | AS900672-Enriched 40 Mcg | Single 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. |
| OG004 | Follitropin Alfa 75 IU | Follitropin 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. |
|
|
| Secondary | Percentage of Participants With Clinical Pregnancy | 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. | PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | Number | Percentage of participants | Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days]) |
|
|
|
| Secondary | Duration of Ovarian Stimulation | Ovarian stimulation included from first dose of study drug on S1 until day on which r-hCG was administered (r-hCG day). | PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | Days | Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle [approximately 14 days]) |
|
|
|
| Secondary | Duration of Supplemental Follitropin Alfa Treatment | PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | Days | Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days]) |
|
|
|
| Secondary | Cumulative Dose of Supplemental Follitropin Alfa Administered | PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | IU | Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days]) |
|
|
|
| Secondary | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points. | Posted | Mean | Standard Deviation | Follicles | Stimulation Day 5 (S5), S7 and r-hCG administration day (end of stimulation cycle [approximately 14 days]) |
|
|
|
| 0 |
| 14 |
| 7 |
| 14 |
| EG001 | AS900672-Enriched 20 Mcg | Single 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 |
| EG002 | AS900672-Enriched 30 Mcg | Single 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 |
| EG003 | AS900672-Enriched 40 Mcg | Single 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 |
| EG004 | Follitropin Alfa 75 IU | Follitropin 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 |
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Breast tenderness | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Adnexa uteri pain | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vaginal pain | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Genital haemorrhage | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
Not provided
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010926 | Placental Hormones |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |
| < 11 mm on S7 (n=12,12,13,12,12) |
|
| < 11 mm on r-hCG Day (n=5,6,7,6,7) |
|
| >= 11 mm on S5 (n=12,8,7,11,8) |
|
| >= 11 mm on S7 (n=11,9,7,11,11) |
|
| >= 11 mm on r-hCG Day (n=5,6,8,6,8) |
|