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To evaluate the efficacy of oral contraceptives in a continuous fashion versus the usual cyclic fashion in the recurrence of endometriosis related symptoms and endometriomas following fertility-sparing surgery.
Oral contraceptives containing 0.03 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for 21 days followed by 7 days pill free (cyclic fashion) or one tablet a day in a continuous fashion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral contraceptives cyclic | Experimental | Oral contraceptives containing 0.03 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for 21 days followed by 7 days pill free. The regimen will be repeated for the duration of the trial. |
|
| Oral contraceptives continuous | Active Comparator | Oral contraceptives containing 0.030 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for the duration of the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral contraceptives cyclic | Drug | tables containing Ethinyl estradiol 0.03mg and drospirenone 3mg will be administered in a cyclic fashion 21 days on 7 days off pill for 6 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic pain | In each visit patients will complete a detailed 25-item self-administered questionnaire (www.endometriosisfoundation.org/WERF-WHSS-Questionnaire-English.pdf) related to the presence of pelvic pain (scoring of pelvic pain) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| recurrence rate for endometrioma | Physical and transvaginal sonographic examination | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| dysmenorrhea | In each visit patients were asked to complete a detailed 25-item self-administered questionnaire (www.endometriosisfoundation.org/WERF-WHSS-Questionnaire-English.pdf) related to the presence of dysmenorrhea (scoring of dysmenorrhea) | 6 months |
Inclusion Criteria:
Women of reproductive age with Symptomatic endometriosis following fertility sparing surgery
Exclusion Criteria:
Contraindications of use of oral contraceptives
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olga B Triantafyllidou, M.D, Msc | Contact | +306944963506 | triantafyllidouolga@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Nikos Vlahos, AssProfessor | University of Athens, 2nd Department of Obstetrics and Gynecology | Study Chair |
| Olga Triantafyllidou, MD | University of Athens, 2nd Department of Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aretaieion Hospital | Recruiting | Athens | Athens | Greece |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| D017699 | Pelvic Pain |
| D004414 | Dyspareunia |
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C534342 | drospirenone and ethinyl estradiol combination |
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|
| Oral contraceptives continuous | Drug | Patients will be treated with oral contraceptives containing 0.03mg ethinyl estradiol and 3 mg drospirenone per day in a continuous fashion. |
|
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |