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Norethindrone for the Delay of Menstruation

Norethindrone Versus Combined Oral Contraceptive Pills for the Delay of Menstruation

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03594604
Enrollment
17
Registered
2018-07-20
Start date
2007-06-15
Completion date
2007-12-15
Last updated
2018-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menstrual Flow Altered

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

Wayne State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

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

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
breakthrough bleeding on treatmentat 2 weeks from starting therapycomparison of breakthrough bleeding between oral contraceptives and norethindrone

Secondary

MeasureTime frameDescription
Likelihood of recommending this method or using it againat 2 weeks from starting theraptyA 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 effectsat 2 weeks from starting therapymeasurement of side effects from norethindrone therapy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026