Hormonal Contraception and Vaginal Health

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Contraceptive Usage; Vaginal Epithelial Disruption

Treatments: Drug: Desogen (ethinyl estradiol and desogestrel); Drug: NuvaRing (ethinyl estradiol and etonogestrel)

Study type: Interventional

Funder types: Other

Identifiers

NCT00612508

OHSU RES 2017

Details and patient eligibility

About

The purpose of this study is to help determine if the route by which women receive hormonal contraception causes different changes to occur in the lining of the vagina. The investigators plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring).

Full description

The investigators intend to conduct a prospective, randomized study at Oregon Health and Science University. This study will be conducted over six 28-day cycles. Subjects enrolled in the study will undergo baseline vaginal biopsy and then be randomized to receive either intravaginal ethinyl estradiol and etonogestrel (NuvaRing®) or oral ethinyl estradiol and desogestrel (Desogen®). Repeat vaginal biopsies will be obtained after three and six months of exposure to either oral or intravaginal hormonal contraception. These will be analyzed to measure the thickness of the vaginal epithelium and to quantify the presence of Langerhans cell, macrophages, T-lymphocytes and dendritic cells.

Enrollment: 14 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female
• 18-35 years
• In general good health
• With regular menses (every 28-32 days)
• Seeking contraception and willing to use a hormonal method for at least 6 months

Exclusion criteria

• Current or recent (within the past 8 weeks) vaginitis or pelvic inflammatory disease
• History of recurrent vaginitis (> 2 episodes in one year, any type)
• Pregnancy
• Recent use of hormonal contraceptives
• Depot medroxyprogesterone: 6 months
• Progestin implants: 3 months
• Oral contraceptives: 3 months
• Hormone impregnated IUD: 3 months
• Contraindications to use of oral contraceptive pills or vaginal ring
• History of deep vein thrombosis
• Known coagulopathy or thrombophilia
• Unexplained vaginal bleeding
• Uncontrolled hypertension
• Diabetes with vascular changes
• Present or history of hepatic disease or liver tumors
• Migraines with neurologic changes
• Myocardial infection
• Pulmonary embolus
• Stroke
• Breast cancer
• Hypersensitivity or allergy to hormonal contraception
• Heavy Smoking ( ≥ 15 cigarettes per day)

Trial design

14 participants in 2 patient groups

Desogen

Active Comparator group

Description:

Drug: ethinyl estradiol and desogestrel 1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol; secen inactive pills every 28 days. Subjects receive baseline vaginal biopsy, followed by treatment with the OC for six cycles and repeat biopsy at 3 and after 6 cycles

Treatment:

Drug: Desogen (ethinyl estradiol and desogestrel)

NuvaRing

Active Comparator group

Description:

Intravaginal Contraception ethinyl estradiol (0.15 mg/d) and etonogestrel (0.12 mg/d) Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring Subjects had baseline vaginal biopsy followed by 6 cycles of ring use and repeat biopsy at 3 and after 6 cycles

Treatment:

Drug: NuvaRing (ethinyl estradiol and etonogestrel)