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OpenTrials
Completed

NCT Number: NCT03594604

Norethindrone for the Delay of Menstruation

Comparison of oral contraceptive pills versus norethindrone to delay menstuation.

Completed

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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:

  • Determine if norethindrone can delay menstruation without breakthrough bleeding
  • Compare norethindrone with oral contraceptive pills for delaying menstruation
  • Compare patient satisfaction of each method
  • Compare side effect profiles of each method

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Norethindrone

Drug

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

Other names: (Aygestin)

oral contraceptive pill

Drug

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

Other names: Combined oral contraceptive pill

Primary outcomes

  1. breakthrough bleeding on treatment

    Time frame: at 2 weeks from starting therapy

    comparison of breakthrough bleeding between oral contraceptives and norethindrone

Secondary outcomes

  1. Likelihood of recommending this method or using it again

    Time frame: 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".

  2. Adverse effects

    Time frame: at 2 weeks from starting therapy

    measurement of side effects from norethindrone therapy

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Official study title

Norethindrone Versus Combined Oral Contraceptive Pills for the Delay of Menstruation

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 20, 2018
Registry last updated
Jul 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.