Norethindrone for the Delay of Menstruation
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|ClinicalTrials.gov Identifier: NCT03594604|
Recruitment Status : Completed
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Menstrual Flow Altered||Drug: Norethindrone Drug: oral contraceptive pill||Phase 4|
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.
- 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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be randomized to receive oral contraceptive pills or norethindrone|
|Masking Description:||Patients will be randomized to receive oral contraceptive pills or norethindrone|
|Official Title:||Norethindrone Versus Combined Oral Contraceptive Pills for the Delay of Menstruation|
|Actual Study Start Date :||June 15, 2007|
|Actual Primary Completion Date :||December 15, 2007|
|Actual Study Completion Date :||December 15, 2007|
Delaying menstruation using Norethindrone 5mg three times daily in women who desire postponement of their period for social or personal reasons.
Women desiring to postpone their periods may be randomized to norethindrone 5mg three times daily.
Other Name: (Aygestin)
Active Comparator: Oral Contraceptive Pills
Women who desire postponing their periods are typically treated with oral contraceptive pills, the current standard of care.
Drug: oral contraceptive pill
Women desiring to postpone their periods may be randomized to daily oral contraceptive pills.
Other Name: Combined oral contraceptive pill
- breakthrough bleeding on treatment [ Time Frame: at 2 weeks from starting therapy ]comparison of breakthrough bleeding between oral contraceptives and norethindrone
- Likelihood of recommending this method or using it again [ Time Frame: 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 [ Time Frame: at 2 weeks from starting therapy ]measurement of side effects from norethindrone therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594604
|Principal Investigator:||Maurice Recanati||St. Vincents Catholic Medical Centers|