Norethindrone for the Delay of Menstruation

Norethindrone Versus Combined Oral Contraceptive Pills for the Delay of Menstruation

Comparison of oral contraceptive pills versus norethindrone to delay menstuation.

Study Overview

• Status: Completed
• Conditions: Menstrual Flow Altered
• Intervention / Treatment: Drug: Norethindrone; Drug: oral contraceptive pill

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Norethindrone; Delaying menstruation using Norethindrone 5mg three times daily in women who desire postponement of their period for social or personal reasons.	Drug: Norethindrone; Women desiring to postpone their periods may be randomized to norethindrone 5mg three times daily.; Other Names: (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 Names: Combined oral contraceptive pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
breakthrough bleeding on treatment	comparison of breakthrough bleeding between oral contraceptives and norethindrone	at 2 weeks from starting therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Likelihood of recommending this method or using it again	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".	at 2 weeks from starting therapty
Adverse effects	measurement of side effects from norethindrone therapy	at 2 weeks from starting therapy

Collaborators and Investigators

• Sponsor: Wayne State University
• Investigators: Principal Investigator: Maurice Recanati, St. Vincents Catholic Medical Centers

Publications and helpful links

General Publications

• Attia AM, Ibrahim MM, Abou-Setta AM. Role of the levonorgestrel intrauterine system in effective contraception. Patient Prefer Adherence. 2013 Aug 9;7:777-85. doi: 10.2147/PPA.S36948. eCollection 2013.
• Yairi-Oron Y, Rabinson J, Orvieto R. A simplified approach to religious infertility. Fertil Steril. 2006 Dec;86(6):1771-2. doi: 10.1016/j.fertnstert.2006.05.050. Epub 2006 Oct 30.
• Chertok IR, Zimmerman DR, Taragin S, Silverman Z, Hallak M. Implications of endometriosis for women who observe Jewish law (halakha). Isr Med Assoc J. 2005 Feb;7(2):71-4.
• Amy JJ, Tripathi V. Contraception for women: an evidence based overview. BMJ. 2009 Aug 7;339:b2895. doi: 10.1136/bmj.b2895. No abstract available.
• Dean J, Kramer KJ, Akbary F, Wade S, Huttemann M, Berman JM, Recanati MA. Norethindrone is superior to combined oral contraceptive pills in short-term delay of menses and onset of breakthrough bleeding: a randomized trial. BMC Womens Health. 2019 May 28;19(1):70. doi: 10.1186/s12905-019-0766-6.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2007
• Primary Completion (Actual): December 15, 2007
• Study Completion (Actual): December 15, 2007

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (Actual): July 20, 2018

Study Record Updates

• Last Update Posted (Actual): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: norethindrone
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Norethindrone; Norethindrone Acetate
• Other Study ID Numbers: 040818M1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No