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| ID | Type | Description | Link |
|---|---|---|---|
| FMH-245-C |
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To compare the efficacy of a combined contraceptive vaginal ring (NuvaRing) and oral Norethisterone Acetate in treatment of Idiopathic heavy menstrual bleeding during fertile age
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NuvaRing | Experimental | For the first cycle, women inserted the ring between days 1 and 5 of the menstrual cycle. Treatment continued for three cycles. Each cycle consisted of 3 weeks of ring use followed by a 1 week ring-free period. |
|
| Norethisterone Acetate | Active Comparator | Norethisterone Acetate tablets at a dose of 5 mg three times daily from day 5 to 26 of the cycle over three cycles. Male condom used for contraception during treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NuvaRing | Drug | For the first cycle, women inserted the ring between days 1 and 5 of the menstrual cycle. Treatment continued for three cycles. Each cycle consisted of 3 weeks of ring use followed by a 1 week ring-free period. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in menstrual blood loss at the end of study (cycle 3) measured by pictorial blood loss assessment chart. |
| Measure | Description | Time Frame |
|---|---|---|
| Haemoglobin and serum ferritin at the end of study (cycle 3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hatem Abu Hashim, MD MRCOG | Mansoura University Hospital | Principal Investigator |
| Waleed El-Sherbini, MD | Mansoura University Hospital | Study Director |
| Mohamed Bazeed, MD | Mansoura University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Hospitals,OB/GYN department | Al Mansurah | Dakahlia Governorate | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18635169 | Background | Matteson KA, Boardman LA, Munro MG, Clark MA. Abnormal uterine bleeding: a review of patient-based outcome measures. Fertil Steril. 2009 Jul;92(1):205-16. doi: 10.1016/j.fertnstert.2008.04.023. Epub 2008 Jul 16. | |
| 15539438 | Background | Oddsson K, Leifels-Fischer B, Wiel-Masson D, de Melo NR, Benedetto C, Verhoeven CH, Dieben TO. Superior cycle control with a contraceptive vaginal ring compared with an oral contraceptive containing 30 microg ethinylestradiol and 150 microg levonorgestrel: a randomized trial. Hum Reprod. 2005 Feb;20(2):557-62. doi: 10.1093/humrep/deh604. Epub 2004 Nov 11. |
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| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C516519 | NuvaRing |
| D000077563 | Norethindrone Acetate |
| ID | Term |
|---|---|
| D009640 | Norethindrone |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
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| Norethisterone Acetate tablets - 5mg | Drug | Norethisterone Acetate tablets 5 mg three times daily from day 5 to 26 of the cycle over three cycles. Male condom used for contraception during treatment |
|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |