An observational study in Hypothalamic-pituitary-ovarian Axis, Gonadotropins, Ethinyl Estradiol, Contraceptive Efficacy, sponsored by University of Southern California. Completed at 1 site in United States. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2019-07-26.
Sponsored by University of Southern California · Observational
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.
196 studies on the registry are indexed under Pituitary Diseases; 31 are open to participants now.
This study's enrollment of 64 is below the median of 126 across 76 observational studies indexed under Pituitary Diseases.
Browse Pituitary Diseases studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
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Healthy, reproductive age women 18 to 35 years old, who were seeking contraception from the general gynecology clinics of the LAC and USC Medical Center were recruited. The research team identified potential candidates who were taking one of 6 possible monophasic COC formulations. Informed consent was obtained from participants by the research staff. To be eligible for participation, women reported regular menstrual cycles prior to COCs, and had taken at least 3 cycles of the same monophasic COC prior to enrollment.
Exclusion Criteria:
These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months
Drug: combined oral contraceptives
Also known as: ALESSE, LOESTRIN, NORDETTE, ORTHOCEPT, ORTHOCYCLEN, ORTHO NOVUM
Follicle-stimulating Hormone
mean FSH on day 7 of the pill free interval
Time frame: Serum blood samples were collected for hormone measurements at the same time daily during the 7 day hormone free interval.
clinic
| Milestone | Healthy Reproductive Age Women |
|---|---|
| Started | 64 |
| Completed | 64 |
| Not completed | 0 |
mean FSH on day 7 of the pill free interval
| milli international units per milliliter | 20 mcg EE | 30 mcg EE | 35 mcg EE |
|---|---|---|---|
| Follicle-stimulating Hormone | 5.01 ± 0.25 | 5.86 ± 0.55 | 6.38 ± 0.60 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Reproductive Age Women | — | 0/64 (0%) | 0/64 (0%) |
| Age, Categorical(Participants) | Healthy Reproductive Age Women |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 64 |
| >=65 years | 0 |
| Age, Continuous(years) | Healthy Reproductive Age Women |
|---|---|
| Mean | 28 (18 to 35) |
| Sex: Female, Male(Participants) | Healthy Reproductive Age Women |
|---|---|
| Female | 64 |
| Male | 0 |
| Region of Enrollment(participants) | Healthy Reproductive Age Women |
|---|---|
| United States | 64 |
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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University of Southern California