Norethindrone for the Delay of Menstruation

Wayne State University

Status and phase: Completed; Phase 4

Conditions: Menstrual Flow Altered

Treatments: Drug: Norethindrone; Drug: oral contraceptive pill

Study type: Interventional

Funder types: Other

Identifiers

NCT03594604

040818M1

Details and patient eligibility

About

Comparison of oral contraceptive pills versus norethindrone to delay menstuation.

Full 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

Enrollment: 17 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• female, age 18-45, regular periods, desires to postpone menstrual period,

Exclusion criteria

• fibroids, irregular menstrual cycle, endometrial polyps, BMI>30

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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17 participants in 2 patient groups

Norethindrone

Experimental group

Description:

Delaying menstruation using Norethindrone 5mg three times daily in women who desire postponement of their period for social or personal reasons.

Treatment:

Drug: Norethindrone

Oral Contraceptive Pills

Active Comparator group

Description:

Women who desire postponing their periods are typically treated with oral contraceptive pills, the current standard of care.

Treatment:

Drug: oral contraceptive pill