Body Weight, Contraception
Conditions
Keywords
Emergency contraception, Obese BMI, Normal BMI
Brief summary
The purpose of this research study is to determine how body weight changes the drug level of an emergency contraceptive pill containing a hormone called levonorgestrel (LNG). This emergency contraceptive is available to women without a prescription, but has recently been found to not work as well to prevent pregnancies in women of higher body weight. The overall goal of this research is to improve the effectiveness of contraception for women, no matter their weight.
Detailed description
To determine if differences exist in the pharmacokinetics (PK) of levonorgestrel-based emergency contraception (LNG-EC) in obese and normal body mass index (BMI) users and test whether doubling the dose of LNG-EC in obese women increases total and free LNG serum concentrations. We enrolled healthy, reproductive-age women with obese and normal BMIs received 1.5 mg LNG orally and then in a subsequent menstrual cycle, the obese group also received 3 mg LNG. Total and free LNG PK parameters were obtained via serum samples through an indwelling catheter at 0, 0.5, 1, 1.5, 2, and 2.5 h. The primary outcome was the difference in total and free LNG concentration maximum (Cmax) between ECx1 and ECx2 in the obese group.
Interventions
DRUGECx1
At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \<25 kg/m2 will have completed study participation.
DRUGECx2
At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)
Sponsors
Medical Research Foundation, Oregon
Oregon Health and Science University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects are between the ages of 18 and 35 * Subjects are in good general health * Subjects have regular menstrual cycles (between 21 and 35 days) * Subjects are willing to use condoms (if you are sexually active with a male partner), subjects are willing to not have sex with men during the study, or subjects have had a tubal ligation (or have a partner who has had a vasectomy) or subjects have a copper intrauterine device (IUD).
Exclusion criteria
* Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian Syndrome * Impaired liver or renal function * Actively seeking or involved in a weight loss program (must be weight stable) * Pregnancy, breastfeeding, or seeking pregnancy; recent (8 week) use of hormonal contraception * Current use of drugs that interfere with metabolism of sex steroids * Smokers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel | Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5 | Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 1.5mg of levonorgestrel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel | Follicular phase of menstrual cycle | Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 3mg of levonorgestrel |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Normal BMI ECx1 5 normal weight women (BMI\<25 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \<25 kg/m2 will have completed study participation. | 5 |
| Obese BMI ECx1 5 obese women (BMI \>30 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \<25 kg/m2 will have completed study participation. | 5 |
| Obese BMI ECx2 5 obese women (BMI \>30 kg/m2) taking 3mg LNG
ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours) | 5 |
| Total | 15 |
Baseline characteristics
| Characteristic | Normal BMI ECx1 | Obese BMI ECx1 | Obese BMI ECx2 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 5 Participants | 15 Participants |
| Region of Enrollment United States | 5 Participants | 5 Participants | 5 Participants | 15 Participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 5 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 5 | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 5 |
Outcome results
Primary
Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel
Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 1.5mg of levonorgestrel
Time frame: Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal BMI ECx1 | Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel | 10.3 ng/mL | Standard Deviation 2.47 |
| Obese BMI ECx1 | Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel | 5.57 ng/mL | Standard Deviation 2.76 |
Secondary
Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel
Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 3mg of levonorgestrel
Time frame: Follicular phase of menstrual cycle
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Obese BMI ECx1 | Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel | 5.57 ng/mL | Standard Deviation 2.48 |
| Obese BMI ECx2 | Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel | 10.52 ng/mL | Standard Deviation 2.76 |