Menstrual Flow Altered
Conditions
Keywords
norethindrone
Brief summary
Comparison of oral contraceptive pills versus norethindrone to delay menstuation.
Detailed description
Many women ask the OBGYN for help in delaying a poorly timed period in order to participate in events that menstruation would normally interfere with. While most OBGYNs prescribe combined oral contraceptives for this purpose, this method often results in unpredictable spotting, especially at the beginning of therapy. Norethindrone, a progesterone agonist, inhibits ovulation through its antagonistic effect at the anterior pituitary, preventing the release of LH. Additionally, it thickens cervical mucus to inhibit sperm migration into the uterine cavity . Norethindrone downregulates estrogen receptors on the endometrium lining preventing endometrial proliferation, enhancing glandular secretion, and maintaining endometrium integrity. Therefore, norethindrone is well suited in preventing the endometrium from breakdown and preventing menstrual bleeding. Indeed, many OBGYNs have consistently used it for this purpose in women who desire to remain fertile. The intention of our study was to compare norethindrone to birth control pills in order to determine the effectiveness at suppressing bleeding and spotting, compare side effect profiles and to find a method allowing women to freely and comfortably participate in their life events. OBJECTIVES: 1. Determine if norethindrone can delay menstruation without breakthrough bleeding 2. Compare norethindrone with oral contraceptive pills for delaying menstruation 3. Compare patient satisfaction of each method 4. Compare side effect profiles of each method
Interventions
Women desiring to postpone their periods may be randomized to norethindrone 5mg three times daily.
Women desiring to postpone their periods may be randomized to daily oral contraceptive pills.
Sponsors
Study design
Masking description
Patients will be randomized to receive oral contraceptive pills or norethindrone
Intervention model description
Patients will be randomized to receive oral contraceptive pills or norethindrone
Eligibility
Inclusion criteria
* female, age 18-45, regular periods, desires to postpone menstrual period,
Exclusion criteria
* fibroids, irregular menstrual cycle, endometrial polyps, BMI\>30
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| breakthrough bleeding on treatment | at 2 weeks from starting therapy | comparison of breakthrough bleeding between oral contraceptives and norethindrone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Likelihood of recommending this method or using it again | at 2 weeks from starting therapty | A questionnaire given to the patient at 2 weeks from starting therapy and containing the question on a scale from 1-5 (5 most likely) how likely are you to recommend this method to a friend or using it again yourself. |
| Adverse effects | at 2 weeks from starting therapy | measurement of side effects from norethindrone therapy |