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Please see "Purpose" statement
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Sponsor has decided to discontinue Luveris® in the United States (US) due to level of customer demand for this product, and not due to any efficacy or safety concerns.
To confirm the efficacy of the 75 IU dose of Luveris® compared to placebo when administered concomitantly with follitropin alfa for induction of clinical pregnancy in women with hypogonadotropic hypogonadism and profound LH deficiency (LH <1.2 IU/L), and to study the efficacy of a lower dose (25 IU) of Luveris® compared to placebo when administered concomitantly with follitropin alfa for induction of follicular development in women with hypogonadotropic hypogonadism and profound LH deficiency (LH <1.2 IU/L).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Luveris® 75 IU | Active Comparator |
| |
| Luveris® 25 IU | Active Comparator |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luveris® 75 IU | Drug | Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 IU will be administered subcutaneously once daily. Duration of treatment cycle will be up to 14 days, or maximum of 21 days (if follicular maturation is imminent, based upon follicular growth and estradiol [E2] levels). Total duration will be of 3 treatment cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Clinical Pregnancy | Clinical pregnancy was defined as the presence of one or more fetal sac with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination. | Stimulation Day 1 up to clinical pregnancy (Day 35-42 post r-hCG administration day [end of stimulation cycle {approximately 21 days}]) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Cumulative Clinical Pregnancy | Clinical pregnancy was defined as the presence of one or more fetal sac with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination. Cumulative clinical pregnancy referred to all clinical pregnancy that occurred during all the 3 treatment cycles. | Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) |
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Inclusion Criteria:
Be premenopausal, between 18 and 40 years of age inclusive on the day of consent
Have a clinical history of hypogonadotropic hypogonadism (World health organization [WHO] Group I type of anovulation) on the basis of congenital or acquired hypothalamic or pituitary endocrine dysfunction in the presence of qualifying screening laboratories
Have no prior treatment cycles with gonadotropins or gonadotropin releasing hormone (GnRH) (gonadotropin naïve)
Have discontinued estrogen-progesterone replacement therapy at least one month before the screening procedure
Have primary or secondary amenorrhea
Have a negative progestin challenge test performed during Screening
Have the following hormonal values in a centrally analyzed fasting blood sample, drawn within 6 weeks before initiation of treatment:
Have an endovaginal pelvic ultrasound scan showing (i) no clinically significant uterine abnormality, (ii) no ovarian tumor or cyst, and (iii) less than or equal to (=<)13 small follicles (mean diameter =<10 milliliter [mm]) on the largest section through each ovary
Have a normal cervical pap smear within 6 months of the initial visit
Where indicated, have a normal or unchanged computed tomography (CT) scan or nuclear magnetic resonance (NMR) scan of the hypothalamic pituitary region on file
Have a body mass index (BMI) between 18.4 and 31.4 kilogram per square meter (kg/m^2)
Be willing and able to comply with the protocol for the duration of the study
Have given written informed consent prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Serono S.A., Geneva | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.S. Medical Information, 1-888-275-7376 | Rockland | Massachusetts | 02370 | United States |
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| Label | URL |
|---|---|
| Full FDA approved prescribing information can be found here | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Luveris® 75 IU | Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Luveris® 25 IU | Drug | Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU will be administered subcutaneously once daily. Duration of treatment cycle will be up to 14 days, or maximum of 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration will be of 3 treatment cycles. |
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| Placebo | Drug | Placebo will be administered subcutaneously once daily. Duration of treatment cycle will be up to 14 days, or maximum of 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration will be of 3 treatment cycles. |
|
| Recombinant human follicle stimulating hormone (r-hFSH) | Drug | Fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU will be administered subcutaneously for 7 days. After 7 days of treatment, if the subject response will suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. Duration of treatment cycle will be up to 14 days, or maximum of 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration will be of 3 treatment cycles. |
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| Recombinant human chorionic gonadotropin (r-hCG) | Drug | When the follicular response will adequate, ovulation will be triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle will be up to 14 days, or maximum of 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration will be of 3 treatment cycles. |
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| Percentage of Participants With Cumulative Ovulation | Ovulation was defined as a mid-luteal phase progesterone (P4) level greater than or equal to (>=) 10 nanogram per milliliter (ng/mL). Cumulative ovulation referred to all ovulations that occurred during all the 3 treatment cycles. | Recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 21 days]) |
| FG001 | Luveris® 25 IU | Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles. |
| FG002 | Placebo | Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Luveris® 75 IU | Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles. |
| BG001 | Luveris® 25 IU | Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles. |
| BG002 | Placebo | Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Time to Clinical Pregnancy | Clinical pregnancy was defined as the presence of one or more fetal sac with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination. | Intention-to-treat (ITT) population included all the participants who received study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | Median | Full Range | Days | Stimulation Day 1 up to clinical pregnancy (Day 35-42 post r-hCG administration day [end of stimulation cycle {approximately 21 days}]) |
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| Secondary | Percentage of Participants With Cumulative Clinical Pregnancy | Clinical pregnancy was defined as the presence of one or more fetal sac with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination. Cumulative clinical pregnancy referred to all clinical pregnancy that occurred during all the 3 treatment cycles. | ITT population included all the participants who received study treatment. | Posted | Number | Percentage of participants | Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Cumulative Ovulation | Ovulation was defined as a mid-luteal phase progesterone (P4) level greater than or equal to (>=) 10 nanogram per milliliter (ng/mL). Cumulative ovulation referred to all ovulations that occurred during all the 3 treatment cycles. | ITT population included all participants who were treated to trial treatment. | Posted | Number | Percentage of participants | Recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 21 days]) |
|
Stimulation Day 1 up to Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Luveris® 75 IU | Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles. | 1 | 5 | 4 | 5 | ||
| EG001 | Luveris® 25 IU | Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles. | 0 | 3 | 1 | 3 | ||
| EG002 | Placebo | Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles. | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia pneumococcal | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA 14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dysstasia | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Adnexa uteri pain | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Uterine spasm | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dyspareunia | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Ovulation pain | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Pelvic discomfort | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Vaginal discharge | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Dry eye | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D037101 | Luteinizing Hormone, beta Subunit |
| D015292 | Glycoprotein Hormones, alpha Subunit |
| C571801 | follitropin alfa |
| D006063 | Chorionic Gonadotropin |
| ID | Term |
|---|---|
| D007986 | Luteinizing Hormone |
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005640 | Follicle Stimulating Hormone |
| D013972 | Thyrotropin |
| D010926 | Placental Hormones |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |
Not provided
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| Male |
|
Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
| OG002 | Placebo | Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles. |
|
|
Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
| OG002 | Placebo | Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles. |
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