Norethindrone for the Delay of Menstruation

Phase 4

Completed

• Conditions: Menstrual Flow Altered
• Interventions: Drug: oral contraceptive pill; Drug: Norethindrone

• Registration Number: NCT03594604
• Lead Sponsor: Wayne State University

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

Study Timeline

• Study Start: 2007-06-15
• Primary Completion: 2007-12-15
• Study Completion: 2007-12-15
• Study First Submitted: 2018-06-18
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-18
• Last Update Submitted: 2018-07-18
• Study First Posted: 2018-07-20
• Last Update Posted: 2018-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Contraceptive Pills	oral contraceptive pill	Women who desire postponing their periods are typically treated with oral contraceptive pills, the current standard of care.
Norethindrone	Norethindrone	Delaying menstruation using Norethindrone 5mg three times daily in women who desire postponement of their period for social or personal reasons.

Primary Outcome Measures

Name	Time	Method
breakthrough bleeding on treatment	at 2 weeks from starting therapy	comparison of breakthrough bleeding between oral contraceptives and norethindrone

Secondary Outcome Measures

Name	Time	Method
Likelihood of recommending this method or using it again	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	at 2 weeks from starting therapy	measurement of side effects from norethindrone therapy