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The purpose of this study is to investigate and compare the safety and efficacy of various doses of the aromatase inhibitor (anastrozole) versus clomiphene citrate in stimulating follicular growth and ovulation in infertile women with ovulatory dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clomiphene Citrate 50 Milligram (mg) | Active Comparator |
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| Clomiphene Citrate 100 mg | Active Comparator |
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| Anastrozole 1 mg | Experimental |
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| Anastrozole 5 mg | Experimental |
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| Anastrozole 10 mg | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anastrozole 1 mg | Drug | Subjects will be administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). |
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| Measure | Description | Time Frame |
|---|---|---|
| Ovulation Rate in Cycle 1 | Ovulation rate was defined as the percentage of subjects who ovulated (mid-luteal Progesteron [P4] level greater than or equal to [>=] 10 nanogram per milliliter [ng/mL] and/or pregnancy). | Up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Clinical Pregnancy in Cycle 1 | Clinical pregnancy was defined as the existence of at least one ultrasonographically confirmed gestational sac in the uterus with fetal heart activity. | Up to 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local US Medical Information | Rockland | Massachusetts | 02370 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clomiphene Citrate 50 Milligram (mg) | Subjects were administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Clomiphene Citrate 50 mg or moved to Clomiphene Citrate 100 mg arm. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Cycle 1 (1 Month) |
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| Anastrozole 5 mg | Drug | Subjects will be administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). |
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| Anastrozole 10 mg | Drug | Subjects will be administered orally with 10 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). |
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| Clomiphene Citrate 50 mg | Drug | Subjects will be administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). |
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| Clomiphene Citrate 100 mg | Drug | Subjects will be administered orally with 100 mg of clomiphene citrate once daily for 5 days in Cycle 2 and 3 (each cycle = approximately 1 month). |
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| FG001 |
| Clomiphene Citrate 100 mg |
Subjects from Clomiphene Citrate 50 mg arm who were re-randomized at the start of Cycle 2 and Cycle 3 and were administered orally with 100 mg of clomiphene citrate once daily for 5 days in Cycle 2 and 3 (each cycle = approximately 1 month) were presented. |
| FG002 | Anastrozole 1 mg | Subjects were administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Anastrozole 1 mg or moved to Anastrozole 10 mg arm. |
| FG003 | Anastrozole 5 mg | Subjects were administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Anastrozole 5 mg or moved to Anastrozole 10 mg arm. |
| FG004 | Anastrozole 10 mg | Subjects were administered orally with 10 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Some of the subjects from Anastrozole 1 mg and 5 mg arms were re-randomized at the start of Cycle 2 and Cycle 3 to Anastrozole 10 mg arm. |
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| NOT COMPLETED |
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| Cycle 2 (1 Month) |
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| Cycle 3 (1 Month) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Clomiphene Citrate 50 mg | Subjects were administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Clomiphene Citrate 50 mg or moved to Clomiphene Citrate 100 mg arm. |
| BG001 | Anastrozole 1 mg | Subjects were administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Anastrozole 1 mg or moved to Anastrozole 10 mg arm. |
| BG002 | Anastrozole 5 mg | Subjects were administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Anastrozole 5 mg or moved to Anastrozole 10 mg arm. |
| BG003 | Anastrozole 10 mg | Subjects were administered orally with 10 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Some of the subjects from Anastrozole 1 mg and 5 mg arms were re-randomized at the start of Cycle 2 and Cycle 3 to Anastrozole 10 mg arm. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Ovulation Rate in Cycle 1 | Ovulation rate was defined as the percentage of subjects who ovulated (mid-luteal Progesteron [P4] level greater than or equal to [>=] 10 nanogram per milliliter [ng/mL] and/or pregnancy). | All Treated population included all treated subjects who received at least one tablet of study drug (clomiphene citrate or anastrozole). | Posted | Number | percentage of subjects | Up to 1 month |
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| Secondary | Number of Subjects With Clinical Pregnancy in Cycle 1 | Clinical pregnancy was defined as the existence of at least one ultrasonographically confirmed gestational sac in the uterus with fetal heart activity. | All Treated population included all treated subjects who received at least one tablet of study drug (CC or anastrozole). | Posted | Number | subjects | Up to 1 month |
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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 | Clomiphene Citrate 50 mg (Cycle 1) | Subjects administered orally with 50 mg of clomiphene citrate once daily for 5 days in cycle 1 were presented. | 1 | 77 | 23 | 77 | ||
| EG001 | Anastrozole 1 mg (Cycle 1) | Subjects administered orally with 1 mg of Anastrozole once daily for 5 days in cycle 1 were presented. | 0 | 79 | 12 | 79 | ||
| EG002 | Anastrozole 5 mg (Cycle 1) | Subjects administered orally with 5 mg of Anastrozole once daily for 5 days in cycle 1 were presented. | 0 | 76 | 17 | 76 | ||
| EG003 | Anastrozole 10 mg (Cycle 1) | Subjects administered orally with 10 mg of Anastrozole once daily for 5 days in cycle 1 were presented. | 0 | 39 | 4 | 39 | ||
| EG004 | Clomiphene Citrate 50 mg (Cycle 2) | Subjects administered orally with 50 mg of clomiphene citrate once daily for 5 days in cycle 2 were presented. | 0 | 43 | 6 | 43 | ||
| EG005 | Clomiphene Citrate 100 mg (Cycle 2) | Subjects administered orally with 100 mg of clomiphene citrate once daily for 5 days in cycle 2 were presented. | 0 | 10 | 2 | 10 | ||
| EG006 | Anastrozole 1 mg (Cycle 2) | Subjects administered orally with 1 mg of Anastrozole once daily for 5 days in cycle 2 were presented. | 0 | 42 | 2 | 42 | ||
| EG007 | Anastrozole 5 mg (Cycle 2) | Subjects administered orally with 5 mg of Anastrozole once daily for 5 days in cycle 2 were presented. | 0 | 52 | 4 | 52 | ||
| EG008 | Anastrozole 10 mg (Cycle 2) | Subjects administered orally with 10 mg of Anastrozole once daily for 5 days in cycle 2 were presented. | 0 | 41 | 7 | 41 | ||
| EG009 | Clomiphene Citrate 50 mg (Cycle 3) | Subjects administered orally with 50 mg of clomiphene citrate once daily for 5 days in cycle 3 were presented. | 0 | 23 | 4 | 23 | ||
| EG010 | Clomiphene Citrate 100 mg (Cycle 3) | Subjects administered orally with 100 mg of clomiphene citrate once daily for 5 days in cycle 3 were presented. | 0 | 10 | 2 | 10 | ||
| EG011 | Anastrozole 1 mg (Cycle 3) | Subjects administered orally with 1 mg of Anastrozole once daily for 5 days in cycle 3 were presented. | 0 | 26 | 1 | 26 | ||
| EG012 | Anastrozole 5 mg (Cycle 3) | Subjects administered orally with 5 mg of Anastrozole once daily for 5 days in cycle 3 were presented. | 0 | 24 | 2 | 24 | ||
| EG013 | Anastrozole 10 mg (Cycle 3) | Subjects were administered orally with 10 mg of Anastrozole once daily for 5 days in cycle 3 were presented. | 0 | 22 | 2 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Adnexa uteri pain | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Breast tenderness | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@merckgroup.com |
| ID | Term |
|---|---|
| D000858 | Anovulation |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| D002996 | Clomiphene |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| Lack of Efficacy |
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| Other |
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| Pregnancy Unrelated to Therapy |
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| Non Resolving Cyst > 25mm |
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| Discontinued Before Start of Cycle 3 |
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| Other |
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| Male |
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