Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity

Hypothalamic-pituitary-ovarian Axis, Gonadotropins, Ethinyl Estradiol, Contraceptive Efficacy Clinical Trial

Official title:

LH, FHS, Estradiol and Progesterone Activity During the 7-Day Hormone-Free Interval of Various Combined Oral Contraceptive Regimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953211
• Other study ID #: Hormone free interval
• Status: Completed

Study information

• Verified date: July 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. primary completion date: December 1998
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypothalamic-pituitary-ovarian Axis, Gonadotropins, Ethinyl Estradiol, Contraceptive Efficacy
• Pituitary Diseases

Intervention

Drug:
• combined oral contraceptives

Locations

Country	Name	City	State
United States	LAC and USC Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Follicle-stimulating Hormone	mean FSH on day 7 of the pill free interval	Serum blood samples were collected for hormone measurements at the same time daily during the 7 day hormone free interval.