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The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DHEA | Experimental | 0.5% DHEA (intravaginal) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DHEA | Drug | Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium | The long-term safety of intravaginal prasterone has been evaluated on different parameters including the endometrium. For this purpose, endometrial biopsies were performed at screening and at the end of the study (52 weeks) or at discontinuation visit for women who were exposed to intravaginal DHEA (prasterone) for at least 12 weeks. At screening, the endometrium had to be atrophic/inactive for women to be enrolled in the study. Only the end-of-study data are presented. | Baseline and Week 52 (or discontinuation) |
| Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels | The long-term safety of intravaginal prasterone has been evaluated on different parameters including the serum levels of DHEA and its metabolites. For this purpose, blood samples were collected at Baseline and different post-Baseline timepoints for the determination of serum steroid levels by a central laboratory using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. The serum levels of dehydroepiandrosterone (DHEA), estradiol (E2) and testosterone (TESTO) obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. | Baseline and Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells). | The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David F Archer, MD | Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EndoCeutics site # 39 | Montgomery | Alabama | 36117 | United States | ||
| EndoCeutics site # 14 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25771041 | Result | Labrie F, Archer DF, Bouchard C, Girard G, Ayotte N, Gallagher JC, Cusan L, Baron M, Blouin F, Waldbaum AS, Koltun W, Portman DJ, Cote I, Lavoie L, Beauregard A, Labrie C, Martel C, Balser J, Moyneur E; Members of the VVA Prasterone Group. Prasterone has parallel beneficial effects on the main symptoms of vulvovaginal atrophy: 52-week open-label study. Maturitas. 2015 May;81(1):46-56. doi: 10.1016/j.maturitas.2015.02.005. Epub 2015 Feb 16. | |
| 26725467 |
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A total of 798 subjects were screened at 41 medical/research sites located in the US (31 centers) and Canada (10 centers) and 530 subjects were randomized. The first subject first visit was on 30-NOV-2010 and the last subject last visit was on 16-JUL-2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.50% DHEA | DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline and Week 52 |
| Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells). | The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. | Baseline and Week 52 |
| Change From Baseline to Week 52 of Vaginal pH. | A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. | Baseline and Week 52 |
| Change From Baseline to Week 52 of Self-assessment of VVA Symptom Dyspareunia | The severity of dyspareunia was evaluated by a questionnaire. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. | Baseline and Week 52 |
| Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness | The severity of vaginal dryness was evaluated by a questionnaire. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. | Baseline and Week 52 |
| Change From Baseline to Week 52 of Self-assessment of VVA Symptom Irritation/Itching | The severity of irritation/itching was evaluated by a questionnaire. The severity of irritation/itching recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. | Baseline and Week 52 |
| Tucson |
| Arizona |
| 85712 |
| United States |
| EndoCeutics site # 21 | Sacramento | California | 95821 | United States |
| EndoCeutics site # 30 | San Diego | California | 92108 | United States |
| EndoCeutics site # 17 | San Diego | California | 92120 | United States |
| EndoCeutics site # 36 | Denver | Colorado | 80218 | United States |
| EndoCeutics site # 42 | Milford | Connecticut | 06460 | United States |
| EndoCeutics site # 07 | Washington D.C. | District of Columbia | 20036 | United States |
| EndoCeutics site # 45 | Boynton Beach | Florida | 33472 | United States |
| EndoCeutics site # 26 | Jacksonville | Florida | 32207 | United States |
| EndoCeutics site # 41 | West Palm Beach | Florida | 33401 | United States |
| EndoCeutics site # 23 | Sandy Springs | Georgia | 30328 | United States |
| EndoCeutics site # 10 | Meridian | Idaho | 83642 | United States |
| EndoCeutics site # 27 | Baltimore | Maryland | 21285-6815 | United States |
| EndoCeutics site # 22 | Kalamazoo | Michigan | 49009 | United States |
| EndoCeutics site # 25 | Lincoln | Nebraska | 68510 | United States |
| EndoCeutics site # 24 | Omaha | Nebraska | 68131 | United States |
| EndoCeutics site # 28 | Moorestown | New Jersey | 08057 | United States |
| EndoCeutics site # 50 | Neptune City | New Jersey | 07753 | United States |
| EndoCeutics site # 44 | New Brunswick | New Jersey | 08901 | United States |
| EndoCeutics site # 19 | New York | New York | 10016 | United States |
| EndoCeutics site # 16 | Durham | North Carolina | 27713 | United States |
| EndoCeutics site # 33 | Beachwood | Ohio | 44122 | United States |
| EndoCeutics site # 05 | Cleveland | Ohio | 44122 | United States |
| EndoCeutics site # 47 | Cleveland | Ohio | 44124 | United States |
| EndoCeutics site # 15 | Columbus | Ohio | 43213 | United States |
| EndoCeutics site # 35 | Pittsburgh | Pennsylvania | 15206 | United States |
| EndoCeutics site # 09 | West Jordan | Utah | 84088 | United States |
| EndoCeutics site # 31 | Charlottesville | Virginia | 22903 | United States |
| EndoCeutics site # 03 | Norfolk | Virginia | 23507 | United States |
| EndoCeutics site # 38 | Renton | Washington | 98055 | United States |
| EndoCeutics site # 13 | Calgary | Alberta | T2N 4L7 | Canada |
| EndoCeutics site # 06 | Bathurst | New Brunswick | E2A 4X7 | Canada |
| EndoCeutics site # 04 | Drummondville | Quebec | J2B 7T1 | Canada |
| EndoCeutics site # 34 | Montreal | Quebec | H2X 3J4 | Canada |
| EndoCeutics site # 12 | Montreal | Quebec | H4N 3C5 | Canada |
| EndoCeutics site # 02 | Québec | Quebec | G1S 2L6 | Canada |
| EndoCeutics site # 01 | Québec | Quebec | G1V 2L9 | Canada |
| EndoCeutics site # 18 | Saint Romuald | Quebec | G6W 5M6 | Canada |
| EndoCeutics site # 08 | Shawinigan | Quebec | G9N 2H6 | Canada |
| EndoCeutics site # 11 | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| Result |
| Bouchard C, Labrie F, Derogatis L, Girard G, Ayotte N, Gallagher J, Cusan L, Archer DF, Portman D, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Group. Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC-230 open-label study. Horm Mol Biol Clin Investig. 2016 Mar;25(3):181-90. doi: 10.1515/hmbci-2015-0044. |
| 26509785 | Result | Ke Y, Gonthier R, Simard JN, Archer D, Lavoie L, Martel C, Vaillancourt M, Labrie F. Serum steroids remain within the same normal postmenopausal values during 12-month intravaginal 0.50% DHEA. Horm Mol Biol Clin Investig. 2015 Dec;24(3):117-29. doi: 10.1515/hmbci-2015-0035. |
| 25968836 | Result | Portman DJ, Labrie F, Archer DF, Bouchard C, Cusan L, Girard G, Ayotte N, Koltun W, Blouin F, Young D, Wade A, Martel C, Dube R; other participating members of VVA Prasterone Group. Lack of effect of intravaginal dehydroepiandrosterone (DHEA, prasterone) on the endometrium in postmenopausal women. Menopause. 2015 Dec;22(12):1289-95. doi: 10.1097/GME.0000000000000470. |
| 26972555 | Result | Martel C, Labrie F, Archer DF, Ke Y, Gonthier R, Simard JN, Lavoie L, Vaillancourt M, Montesino M, Balser J, Moyneur E; other participating members of the Prasterone Clinical Research Group. Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12 weeks. J Steroid Biochem Mol Biol. 2016 May;159:142-53. doi: 10.1016/j.jsbmb.2016.03.016. Epub 2016 Mar 10. |
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline Analysis Population corresponds to the Safety Population which includes all subjects who received any amount of DHEA, and who have any safety information available.
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.50% DHEA | DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks. |
| 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/Gender, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | 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 | Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium | The long-term safety of intravaginal prasterone has been evaluated on different parameters including the endometrium. For this purpose, endometrial biopsies were performed at screening and at the end of the study (52 weeks) or at discontinuation visit for women who were exposed to intravaginal DHEA (prasterone) for at least 12 weeks. At screening, the endometrium had to be atrophic/inactive for women to be enrolled in the study. Only the end-of-study data are presented. | Only subjects in the Safety Population who had an end-of-study endometrial biopsy are included in the analysis. | Posted | Count of Participants | Participants | Baseline and Week 52 (or discontinuation) |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells). | The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. | Subgroups of the Safety Population were used for analysis. The subgroup identified "ALL" includes subjects meeting or not the vulvovaginal atrophy (VVA) criteria at Baseline while the subgroup "VVA" only includes subjects meeting VVA criteria (pH ˃5, superficial cells ≤ 5% and moderate/severe VVA symptom being most bothersome (MBS)). | Posted | Mean | Standard Error | percentage of parabasal cells | Baseline and Week 52 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells). | The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. | Subgroups of the Safety Population were used for analysis. The subgroup identified "ALL" includes subjects meeting or not the vulvovaginal atrophy (VVA) criteria at Baseline while the subgroup "VVA" only includes subjects meeting VVA criteria (pH ˃5, superficial cells ≤ 5% and moderate/severe VVA symptom being most bothersome (MBS)). | Posted | Mean | Standard Error | percentage of superficial cells | Baseline and Week 52 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 52 of Vaginal pH. | A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. | Subgroups of the Safety Population were used for analysis. The subgroup identified "ALL" includes subjects meeting or not the vulvovaginal atrophy (VVA) criteria at Baseline while the subgroup "VVA" only includes subjects meeting VVA criteria (pH ˃5, superficial cells ≤ 5% and moderate/severe VVA symptom being most bothersome (MBS)). | Posted | Mean | Standard Error | pH | Baseline and Week 52 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 52 of Self-assessment of VVA Symptom Dyspareunia | The severity of dyspareunia was evaluated by a questionnaire. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. | Overall, 476 subjects met vulvovaginal atrophy (VVA) criteria by having moderate/severe (MS) dyspareunia, dryness and/or irritation/itching. The analysis "MS" dyspareunia only includes subjects having MS dyspareunia (being or not most bothersome (MBS)) (n=240); the analysis "MBS/MS" only includes subjects with MS dyspareunia being MBS (n=183). | Posted | Mean | Standard Error | units on a scale | Baseline and Week 52 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness | The severity of vaginal dryness was evaluated by a questionnaire. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. | Overall, 476 subjects met vulvovaginal atrophy (VVA) criteria by having moderate/severe (MS) dyspareunia, dryness and/or irritation/itching. The analysis "MS" only includes subjects having MS dryness (being or not most bothersome (MBS)) (n=251); the analysis "MBS/MS" only includes subjects with MS dryness being MBS (n=81). | Posted | Mean | Standard Error | units on a scale | Baseline and Week 52 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 52 of Self-assessment of VVA Symptom Irritation/Itching | The severity of irritation/itching was evaluated by a questionnaire. The severity of irritation/itching recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. | Overall, 476 subjects met vulvovaginal atrophy (VVA) criteria by having moderate/severe (MS) dyspareunia, dryness and/or irritation/itching. The analysis "MS" only includes subjects having MS irritation/itching (being or not most bothersome (MBS)) (n=86); the analysis "MBS/MS" only includes subjects with MS irritation/itching being MBS (n=23). | Posted | Mean | Standard Error | units on a scale | Baseline and Week 52 |
|
| |||||||||||||||||||||||||||||||||
| Primary | Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels | The long-term safety of intravaginal prasterone has been evaluated on different parameters including the serum levels of DHEA and its metabolites. For this purpose, blood samples were collected at Baseline and different post-Baseline timepoints for the determination of serum steroid levels by a central laboratory using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. The serum levels of dehydroepiandrosterone (DHEA), estradiol (E2) and testosterone (TESTO) obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. | Data are presented for subjects in the Safety Population who have steroid data at both baseline and Week 52. | Posted | Mean | Standard Error | pg/mL | Baseline and Week 52 |
|
|
From Baseline to Week 52 (+ 30-day follow-up period after last dose)
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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 | 0.50% DHEA | DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks. | 18 | 521 | 177 | 521 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Duodenal stenosis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Infectious peritonitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Ovarian cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cystocele repair | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
| |
| Hysterectomy | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
| |
| Rectocele repair | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site discharge | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
Investigators shall provide to the SPONSOR 30 days prior to submission all documents for publication, presentation, etc that report any trial results. The SPONSOR shall have editorial rights on documents and the right to review/comment with regard to (1) proprietary information, (2) accuracy of the information, (3) correctness of the scientific evaluation/conclusions and (4) to ensure that the information is fairly balanced and in compliance with regulations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Data Analysis | Endoceutics | 418-653-0033 | 215 | celine.martel@endoceutics.com |
| ID | Term |
|---|---|
| D059268 | Atrophic Vaginitis |
| ID | Term |
|---|---|
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003687 | Dehydroepiandrosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015068 | 17-Ketosteroids |
| D007664 | Ketosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
Not provided
Not provided
| Asian |
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| American Indian or Alaska Native |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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