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It was in the best interest of the investigator to terminate the study earlier than anticipated.
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Effects of norethindrone acetate (NTA) in patients with Nexplanon.
The purpose of this study is to find out what effects norethindrone acetate (NTA) has on the duration and recurrence of frequent and/or prolonged bleeding associated with Nexplanon™.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Placebo to Norethindrone acetate (NTA) |
|
| Treatment Group | Active Comparator | Norethindrone acetate (NTA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norethindrone acetate (NTA) | Drug | norethindrone acetate, 5 mg tablet, orally, once daily for 7 consecutive days, every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of days of bleeding and spotting | To evaluate days of bleeding and spotting within 90-day intervals by quantifying a self-perception of amount of bleeding on a scale of 0 to 4 and associated symptoms on a scale of 0 to 10 using the Daily Dairy of Symptoms | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life measurements | To evaluate quality of life by comparing the treatment and placebo groups' associated symptoms on a scale of 0 to 10 using the Daily Diary of Symptoms. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanna Stacey, MD | Baylor Reserach Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Research Institute | Temple | Texas | 76502 | United States |
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| ID | Term |
|---|---|
| D008796 | Metrorrhagia |
| D014592 | Uterine Hemorrhage |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077563 | Norethindrone Acetate |
| ID | Term |
|---|---|
| D009640 | Norethindrone |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
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| Placebo | Drug | Placebo, tablet, orally, once daily for 7 consecutive days, every 4 weeks |
|
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |