Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Assess the psychometric properties of the Endometriosis Symptom Diary (ESD) and the Endometriosis Impact Scale (EIS) and provide evidence whether the PRO measures are reliable, valid and able to detect changes over time in approximately 250 patients with mild, moderate or severe endometriosis confirmed by laparoscopy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
| ||
| Group 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No drug | Other | Patients with expected stable endometriosis management status (EMS), i.e. patients who have not planned a change in endometriosis treatment or a therapeutic surgical procedure in the next 12 weeks and have had no change in endometriosis treatment or therapeutic surgical procedure in the previous 4 weeks.lease specify as free-text; for drugs include daily dose, dosage form dosage frequency and duration (if appl. and possible for the OS/NIS). |
| Measure | Description | Time Frame |
|---|---|---|
| Endometriosis symptoms rated by the Endometriosis Symptom Diary | Up to 24 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Women with endometriosis confirmed by laparoscopy
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonesboro | Arkansas | 72401 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29884234 | Derived | Seitz C, Lanius V, Lippert S, Gerlinger C, Haberland C, Oehmke F, Tinneberg HR. Patterns of missing data in the use of the endometriosis symptom diary. BMC Womens Health. 2018 Jun 8;18(1):88. doi: 10.1186/s12905-018-0578-0. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| No drug | Other | Patients with expected change in endometriosis management status (EMS), i.e. patients who have planned a change in endometriosis treatment or a therapeutic surgical procedure during the next 12 weeks or have undergone a change in endometriosis treatment or a therapeutic surgical procedure in the previous 4 weeks. |
|
| Sacramento |
| California |
| 95816 |
| United States |
| San Diego | California | 92103 | United States |
| San Diego | California | 92108 | United States |
| San Francisco | California | 94102 | United States |
| New Haven | Connecticut | 06511 | United States |
| Decatur | Georgia | 30034 | United States |
| Champaign | Illinois | 61820 | United States |
| Worcester | Massachusetts | 01655 | United States |
| Rochester | Minnesota | 55905 | United States |
| Brooklyn | New York | 11203 | United States |
| Greensboro | North Carolina | 27408 | United States |
| Cincinnati | Ohio | 45242 | United States |
| Portland | Oregon | 97239 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| San Angelo | Texas | 76904 | United States |
| Salt Lake City | Utah | 84107 | United States |
| Sandy City | Utah | 84070 | United States |
| Norfolk | Virginia | 23502 | United States |
| Seattle | Washington | 98105 | United States |
| Many Locations | Germany |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| 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