Norethindrone for the Delay of Menstruation

Study Overview
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Brief Summary
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Comparison of oral contraceptive pills versus norethindrone to delay menstuation.

Detailed Description
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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: Determine if norethindrone can delay menstruation without breakthrough bleeding Compare norethindrone with oral contraceptive pills for delaying menstruation Compare patient satisfaction of each method Compare side effect profiles of each method

Official Title
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Norethindrone Versus Combined Oral Contraceptive Pills for the Delay of Menstruation

Conditions
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Menstrual Flow Altered

Intervention / Treatment
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* Drug: Norethindrone
* Drug: oral contraceptive pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female, age 18-45, regular periods, desires to postpone menstrual period, Exclusion Criteria: fibroids, irregular menstrual cycle, endometrial polyps, BMI>30

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized to receive oral contraceptive pills or norethindrone
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Norethindrone<br>Delaying menstruation using Norethindrone 5mg three times daily in women who desire postponement of their period for social or personal reasons. | Drug: Norethindrone<br>* Women desiring to postpone their periods may be randomized to norethindrone 5mg three times daily.<br>* Other names: (Aygestin);|
| Active Comparator: Oral Contraceptive Pills<br>Women who desire postponing their periods are typically treated with oral contraceptive pills, the current standard of care. | Drug: oral contraceptive pill<br>* Women desiring to postpone their periods may be randomized to daily oral contraceptive pills.<br>* Other names: Combined oral contraceptive pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breakthrough bleeding on treatment | comparison of breakthrough bleeding between oral contraceptives and norethindrone | at 2 weeks from starting therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likelihood of recommending this method or using it again | 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. | at 2 weeks from starting therapty | 
| Adverse effects | measurement of side effects from norethindrone therapy | at 2 weeks from starting therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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norethindrone