Clincosm LogoSign in Get a demo

Norethindrone for the Delay of Menstruation

Sponsor
Wayne State University (Other)
Overall Status
Completed
CT.gov ID
NCT03594604
Collaborator
(none)
17
Enrollment
2
Arms
6
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Comparison of oral contraceptive pills versus norethindrone to delay menstuation.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients will be randomized to receive oral contraceptive pills or norethindronePatients will be randomized to receive oral contraceptive pills or norethindrone
Masking:
Single (Investigator)
Masking Description:
Patients will be randomized to receive oral contraceptive pills or norethindrone
Primary Purpose:
Prevention
Official Title:
Norethindrone Versus Combined Oral Contraceptive Pills for the Delay of Menstruation
Actual Study Start Date :
Jun 15, 2007
Actual Primary Completion Date :
Dec 15, 2007
Actual Study Completion Date :
Dec 15, 2007

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. breakthrough bleeding on treatment [at 2 weeks from starting therapy]

      comparison of breakthrough bleeding between oral contraceptives and norethindrone

    Secondary Outcome Measures

    1. 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".

    2. Adverse effects [at 2 weeks from starting therapy]

      measurement of side effects from norethindrone therapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • female, age 18-45, regular periods, desires to postpone menstrual period,
    Exclusion Criteria:
    • fibroids, irregular menstrual cycle, endometrial polyps, BMI>30

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Wayne State University

    Investigators

    • Principal Investigator: Maurice Recanati, St. Vincents Catholic Medical Centers

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Maurice-Andre Recanati, Assistant Professor, Clinical Educator, Wayne State University
    ClinicalTrials.gov Identifier:
    NCT03594604
    Other Study ID Numbers:
    • 040818M1
    First Posted:
    Jul 20, 2018
    Last Update Posted:
    Jul 20, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Maurice-Andre Recanati, Assistant Professor, Clinical Educator, Wayne State University
    norethindrone
    Additional relevant MeSH terms:
    Contraceptive Agents
    Norethindrone
    Norethindrone Acetate
    Contraceptives, Oral
    Contraceptives, Oral, Combined

    Study Results

    No Results Posted as of Jul 20, 2018