Ovulation Incidence in Oral Contraceptive Users

Contraception Clinical Trial

Official title:

Ovulation Incidence in Oral Contraceptive Users

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03106454
• Other study ID #: HS-09-00669
• Status: Suspended
• Phase: Phase 3
• Start date: August 2014
• Est. completion date: January 2024

Study information

• Verified date: January 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Since the introduction of the combined hormonal contraceptive pill, dosages of ethinyl estradiol (EE) have steadily decreased from more than 150mcg to 20mcg in an attempt to improve the risk profile associated with the COC. In 2010, the Food and Drug Administration approved a oral contraceptive pill containing EE 10mcg/NET acetate 1mg (Tradename Lo loestrin). However, no studies have compared this formulation to pills containing either higher doses of estrogen or progestin alone. It is not known whether EE 10mcg is sufficient to prevent follicular development or to support the endometrium as well as higher doses of EE. This trial addresses the question of whether an oral contraceptive pill with EE 10mcg/Norethindrone acetate 1mg will better suppress ovulation or have a better side effect profile than a progestin only pill with a nearly equal dose of norethindrone.

Description:

Use of combined hormonal contraceptives (CHC) containing estrogen is associated with venous thromboembolic events. In an effort to decrease the risks of estrogen, the dose of ethinyl estradiol (EE) contained in combined oral contraceptive (COC) pills has decrease substantially from >100mcg to 20mcg. In 2012, a COC with only 10mcg of EE (Tradename LoLoestrin) was approved by the Food and Drug Administration. However, no studies have compared this formulation to pills containing progestin alone to determine if this very low dose of EE decreases ovulation or improves unscheduled uterine bleeding beyond what is seen with a progestin only pill (POP).

We aim to compare a COC with EE 10mcg/norethindrone (NET) acetate 1mg to a POP containing a nearly equal amount of progestin (norethindrone 1.05mg). The objective of the study is to compare the incidence of ovulation among users of a COC with only EE10mcg/NET acetate 1mg to users of a POP with a nearly identical progestin dose of NET 1.05mg. We plan to recruit 58 women between the ages of 18 and 45 years old, who are ovulatory at baseline based on serum progesterone levels. Subjects will be randomized to take either a COC containing EE 10mcg/NET acetate 1mg or a POP containing NET 1.05mg for one month. During the month of study treatment, we will measure ovulation incidence using a single serum progesterone levels of >=4.0ng/dl, sperm penetration of cervical mucus using the Eggert Kruse classification system, pill compliance by NET serum levels, and side effects including unscheduled uterine bleeding via subject daily diaries.

Our primary outcome, ovulation incidence, will be compared between study arms. Secondary outcomes will compare cervical mucus quality, sperm penetration of cervical mucus, side effects (including uterine bleeding), and pill compliance between users of these two pills.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 58
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Reproductive aged women 18-45 years old.

• Menstrual cycle length 25-35days

• BMI less than or equal to 40

• English or Spanish speaking

Exclusion Criteria:

• Pregnant or breastfeeding in the previous 3 months.

• Use of OC, hormonal vaginal rings or patches, levonorgestrel containing intrauterine device, or etonogestrel implant in the previous 1 month. No use of depot medroxyprogesterone acetate (DMPA) injection in the previous 6 months and at least one menses since discontinuation.

• Medical contraindications to estrogen or progestin use. Specifically: smoking among participants over 35 years old, migraines with aura, history of blood clots, ischemic heart disease, stroke, breast cancer, cervical cancer, liver disease, symptomatic gallbladder disease, uncontrolled hypertension, antiphospholipid antibody syndrome, hyperlipidemia, diabetes with end organ damage (retinopathy, nephropathy, neuropathy) or diagnosis >20 years ago, organ transplant

• Desire to become pregnant in the next 4 months

Related Conditions & MeSH terms

• Contraception
• Ovulation

Intervention

Drug:
• Ethinyl Estradiol, Norethindrone acetate, ferrous fumarate
Combination Oral Contraceptive Pill. Ethinyl Estradiol 10mcg/Norethindrone acetate 1mg/ferrous fumarate 75mg
• Norethindrone
Norethindrone 1.05mg

Locations

Country	Name	City	State
United States	Brian T. Nguyen	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pill complaince	Number of pills missed or forgotten over the course of a single 28 day cycle	A single 28 day cycle
Primary	Ovulation	Ovulation based on a single serum progesterone level of 4ng/dl or greater	A single 28 day cycle
Secondary	Sperm penetration of cervical mucus	The average distance sperm will travel in vitro in a test tube of cervical mucus collected from the participant.	A single 28 day cycle
Secondary	Cervical mucus quality	Scoring of the ovulatory quality (thickness, cellularity, etc.) of cervical mucus collected from the participant	A single 28 day cycle
Secondary	Side effects	Side effects self reported by the participant	A single 28 day cycle
Secondary	Uterine bleeding	A daily calendar counting the number of days of uterine bleeding participants experience during the study cycle.	A single 28 day cycle