N/A
Completed N=64
Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity
Hypothalamic-pituitary-ovarian Axis, Gonadotropins, Ethinyl Estradiol, Contraceptive Efficacy
Source: ClinicalTrials.gov NCT01953211 ↗
Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Follicle-stimulating Hormone — 5.01; 5.86; 6.38 milli international units per milliliter — p=0.88
Summary
The degree of suppression and subsequent activation of the hypothalamic-pituitary-ovarian axis during the hormone-free interval in combined oral contraceptive (COC) hormone users varies depending on the dose of ethinyl estradiol in the formulation. This variation in activation may be associated with different side effects during the hormone free interval. Progesterone (P) remained suppressed during all 6 COC regimens (<1.8 ng/mL), which indicates continuous contraceptive efficacy during the 7-day hormone free interval of all formulations studied.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Follicle-stimulating Hormone |
5.01; 5.86; 6.38 | 0.88 |
Eligibility Criteria
Inclusion Criteria
- Healthy, reproductive age women
- 18 to 35 years old,
- seeking contraception from the general gynecology clinics of the LAC and USC Medical Center w
- taking one of 6 possible monophasic COC formulations for at least 3 cycles prior to enrollment
- regular menstrual cycles prior to COCs
Exclusion Criteria
- Irregular bleeding
- bilateral oophorectomy
- amenorrhea
- hormone-sensitive cancer
- concurrent medications known to interfere with steroid metabolism (i.e., barbiturates, phenytoin, carbamazepine, ethosuximide, primidone, rifampin, tetracycline)
Data sourced from ClinicalTrials.gov (NCT01953211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.