Norethindrone
DrugWomen desiring to postpone their periods may be randomized to norethindrone 5mg three times daily.
Other names: (Aygestin)
NCT Number: NCT03594604
Comparison of oral contraceptive pills versus norethindrone to delay menstuation.
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Notify Me18 year–45 year
Female
Interventional
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.
OBJECTIVES:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Women desiring to postpone their periods may be randomized to norethindrone 5mg three times daily.
Other names: (Aygestin)
Women desiring to postpone their periods may be randomized to daily oral contraceptive pills.
Other names: Combined oral contraceptive pill
Time frame: at 2 weeks from starting therapy
comparison of breakthrough bleeding between oral contraceptives and norethindrone
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".
Time frame: at 2 weeks from starting therapy
measurement of side effects from norethindrone therapy
Wayne State University
Other
Norethindrone Versus Combined Oral Contraceptive Pills for the Delay of Menstruation
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