CompletedNot Applicable

Evaluation of the Contraceptive Efficacy

Egypt300 participantsStarted 2023-08-10

Plain-language summary

Combined oral contraceptives are not the preparation of first choice in breastfeeding women as they may influence the quality and quantity of breast milk. In these cases, a progestogen-only pill is a suitable alternative, since progestogen-only pills contain no estrogen at all and a much lower dose of progestogen than do combined oral contraceptives Therefore, progestogen-only pills may also be more acceptable than combined oral contraceptives to women suffering from medical conditions that are associated with the use of combined oral contraceptives (e.g. nausea, headache and breast tension).

Who can participate

Age range35 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age: 18 - 45 years. * Non obese women with BMI between 18.5 : 29.9 kg/m2. * Healthy women with good physical and mental health. * Sexually active. * Women have normal cycles (regular interval, duration, and amount of bleeding. * Women willing to accurately fill in the diary card with daily information on vaginal bleeding and pill intake * Women willing to give written informed consent. Exclusion Criteria: * obese medical history * Contraindications to the use of progesterone only pills with medical eligibility criteria mec category 3 or 4: (malabsorptive procedures, current or history of ischemic heart disease, history of cerebrovascular accident, systemic lupus erythematosus, breast cancer, cirrhosis, liver tumors or antimicrobial therapy). * Women with allergy from study medications. * Women refusing to participate in the study.

What they're measuring

Irregular Vaginal Bleeding

Timeframe: 9 Months

Trial details

NCT IDNCT06689150

SponsorAl-Azhar University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-01