Norethindrone for the Delay of Menstruation

NCT ID: NCT03594604

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-15
• Study Completion Date: 2007-12-15

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

Conditions

Menstrual Flow Altered

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Norethindrone

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

Group Type: EXPERIMENTAL

Norethindrone

Intervention Type: DRUG

Women desiring to postpone their periods may be randomized to norethindrone 5mg three times daily.

Oral Contraceptive Pills

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

Group Type: ACTIVE_COMPARATOR

oral contraceptive pill

Intervention Type: DRUG

Women desiring to postpone their periods may be randomized to daily oral contraceptive pills.

Interventions

Norethindrone

Women desiring to postpone their periods may be randomized to norethindrone 5mg three times daily.

Intervention Type: DRUG

oral contraceptive pill

Women desiring to postpone their periods may be randomized to daily oral contraceptive pills.

Intervention Type: DRUG

Other Intervention Names

(Aygestin); Combined oral contraceptive pill

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Maurice-Andre Recanati

Assistant Professor, Clinical Educator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maurice Recanati

Role: PRINCIPAL_INVESTIGATOR

St. Vincents Catholic Medical Centers

References

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.

Reference Type: BACKGROUND

PMID: 23990713 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17074351 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15729953 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19666684 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31138184 (View on PubMed)

Other Identifiers

040818M1

Identifier Type: -

Identifier Source: org_study_id