Hypothalamic-pituitary-ovarian Axis, Gonadotropins, Ethinyl Estradiol, Contraceptive Efficacy
Conditions
Brief 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.
Interventions
Sponsors
University of Southern California
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Follicle-stimulating Hormone | Serum blood samples were collected for hormone measurements at the same time daily during the 7 day hormone free interval. | mean FSH on day 7 of the pill free interval |
Countries
United States
Participant flow
Recruitment details
clinic
Pre-assignment details
voluntary
Participants by arm
| Arm | Count |
|---|---|
| Healthy Reproductive Age Women | 64 |
| Total | 64 |
Baseline characteristics
| Characteristic | Healthy Reproductive Age Women |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants |
| Age, Continuous | 28 years |
| Region of Enrollment United States | 64 participants |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 64 |
| serious Total, serious adverse events | 0 / 64 |
Outcome results
Primary
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.
Population: Of note 1 person from the 20 and another from the 30 mcg EE groups hand significant loss of sample and poor processing due to limitations with processing and transport. As a result of this not all participants were able to contribute data for analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 20 mcg EE | Follicle-stimulating Hormone | 5.01 milli international units per milliliter | Standard Deviation 0.25 |
| 30 mcg EE | Follicle-stimulating Hormone | 5.86 milli international units per milliliter | Standard Deviation 0.55 |
| 35 mcg EE | Follicle-stimulating Hormone | 6.38 milli international units per milliliter | Standard Deviation 0.6 |
p-value: 0.88t-test, 2 sided
p-value: <0.01t-test, 2 sided
p-value: <0.01t-test, 2 sided