Initial clinical studies of intravaginal rings containing norethindrone and norgestrel.

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  • Author(s): Mishell DR Jr; lumkin M; Jackanicz T
  • Source:
    Contraception [Contraception] 1975 Sep; Vol. 12 (3), pp. 253-60.
  • Publication Type:
    Comparative Study; Journal Article
  • Language:
    English
  • Additional Information
    • Source:
      Publisher: Elsevier Country of Publication: United States NLM ID: 0234361 Publication Model: Print Cited Medium: Print ISSN: 0010-7824 (Print) Linking ISSN: 00107824 NLM ISO Abbreviation: Contraception
    • Publication Information:
      Publication: New York : Elsevier
      Original Publication: Los Altos, Calif., Geron-X.
    • Subject Terms:
      Contraceptive Devices, Female*; Norethindrone/*pharmacology ; Norgestrel/*pharmacology ; Vagina/*drug effects; Adult ; Delayed-Action Preparations ; Evaluation Studies as Topic ; Female ; Humans ; Ovulation/drug effects ; Progesterone/blood
    • Contributed Indexing:
      Indexing Agency: PIP Local ID #: 751516. Indexing Agency: POP Local ID #: 00020307.
      Keywords: Bleeding; Clinical Research*; Contraception; Contraceptive Agents, Female--administraction and dosage; Contraceptive Agents, Female--side effects; Contraceptive Agents, Progestin--administraction and dosage; Contraceptive Agents, Progestin--side effects; Contraceptive Agents--administraction and dosage; Contraceptive Agents--side effects; Contraceptive Methods--side effects; Contraceptive Usage; Diseases; Evaluation*; Family Planning; Human Volunteers*; Incidence*; Iud, Hormone Releasing--side effects*; Iud--side effects*; Measurement; Method Acceptability*; Metrorrhagia*; Norethindrone--administraction and dosage*; Norethindrone--side effects*; Norgestrel--administraction and dosage*; Norgestrel--side effects*; Ovulation*; Reproduction; Research Methodology; Signs And Symptoms
      Local Abstract: [PIP] 29 volunteer subjects aged 21-40 with regular menstrual cycles were given intravaginal rings (IVRs) made of polysiloxane containing various doses of norethindrone and norgestrel. All pretreatment cycles and posttreatment recovery cycles were ovulatory, except 1. Out of a total of 193 treatment cycles patient acceptance was good with normal vaginal mucosa. When IVRs with 100 and 200 mg norethindrone were in place there was a high incidence of bleeding, an offensive odor, and ovulation occurred in 1/4 of treatment cycles. 50 and 100 mg norgestrel IVRs caused a lower incidence of bleeding and ovulation, but a previous study with similar rings containing medroxyprogesterone acetate (MPA) produced more favorable results. Further clinical trials with MPA are under way, and it is planned to make polysiloxane devices of different design with norgestrel as well as other C-19-nor-testosterone gestagens.
    • Accession Number:
      0 (Delayed-Action Preparations)
      3J8Q1747Z2 (Norgestrel)
      4G7DS2Q64Y (Progesterone)
      T18F433X4S (Norethindrone)
    • Publication Date:
      Date Created: 19750911 Date Completed: 19751211 Latest Revision: 20190824
    • Publication Date:
      20250114
    • Accession Number:
      10.1016/0010-7824(75)90086-4
    • Accession Number:
      1164845