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Related Experiment Videos

Triphasic Randomized Clinical Trial: comparative frequency of intermenstrual bleeding.

W Droegemueller1, L R Katta, T G Bright

  • 1Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill 27599-7590.

American Journal of Obstetrics and Gynecology
|November 1, 1989
PubMed
Summary

Patient compliance with oral contraceptives is key. A clinical trial found significant differences in intermenstrual bleeding between different triphasic oral contraceptives, impacting discontinuation rates.

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Area of Science:

  • Reproductive Health
  • Pharmacology
  • Clinical Trials

Background:

  • Oral contraceptives (OCs) offer high theoretical efficacy but practical failure rates are influenced by patient compliance.
  • Intermenstrual bleeding, a common side effect, significantly contributes to OC discontinuation.

Purpose of the Study:

  • To compare the incidence of intermenstrual bleeding among three different triphasic oral contraceptives.
  • To assess the impact of specific formulations on patient adherence and side effect profiles.

Main Methods:

  • A randomized clinical trial involving three groups of subjects using different triphasic oral contraceptives: NET (A) (Ortho-Novum 7/7/7), LNG (Tri-Levlen), and NET (B) (Tri-Norinyl).
  • Incidence of intermenstrual bleeding (breakthrough bleeding or spotting) was recorded and compared between groups.

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  • A control group experienced no breakthrough bleeding and a 4% incidence of spotting.
  • Main Results:

    • The incidence of intermenstrual bleeding was highest in the NET (A) group (63%), followed by NET (B) (44%), and LNG (33%).
    • The difference in bleeding incidence between NET (A) and LNG was statistically significant (p < 0.030).

    Conclusions:

    • Formulation of triphasic oral contraceptives significantly influences the occurrence of intermenstrual bleeding.
    • Further research is needed to elucidate the reasons for observed disparities in side effect incidence among different OCs.