NCT00796133

Brief Summary

This is a Phase 2, dose-finding, cross-over study for the purposes of evaluating the effect of a NES/E2 transdermal gel delivery on ovulation suppression in normal ovulating women.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_2

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 24, 2008

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

5.2 years

First QC Date

November 21, 2008

Last Update Submit

April 16, 2015

Conditions

Ovulation

Keywords

NES/E2transdermal gel deliverycontraceptionovulationbleeding patterns

Outcome Measures

Primary Outcomes (1)

  • Determine with ultrasound scan (USS) measures and serum progesterone (P) assessment the lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P<10nmol/L) in 90-95% of the cycles

    Subjects will remain in the study for approximately 8 months

Secondary Outcomes (3)

  • Determine with USS and E2 serum levels the dose that can suppress follicle growth and replace estradiol at the physiological early follicular phase level

    Subjects will remain in the study for approximately 8 months

  • Evaluate the correlation of NES and E2 serum levels with the percentage of ovulation suppression

    Subjects will remain in the study for approximately 8 months

  • Evaluate the safety and tolerability of the formulations

    Subjects will remain in the study for approximately 8 months

Study Arms (3)

1

ACTIVE COMPARATOR

0.5 ml of NES/E2 equaling 0.45 g and contains 1.5 mg NES/0.5 mg E2

Drug: NES/E2 gel

2

ACTIVE COMPARATOR

1.0 ml of NES/E2 gel equaling 0.9 g and contains 3.0 mg NES/1.0 mg E2

Drug: NES/E2 gel

3

ACTIVE COMPARATOR

1.5 ml of NES/E2 gel equaling 4.5 mg NES/1.5 mg E2

Drug: NES/E2 gel

Interventions

NES/E2 gelDRUG

Lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P\<10nmol/L) in 90-95% of the cycles. The high dose will deliver 4.5mg of NES; the medium dose will deliver 3mg of NES, and a low dose of 1.5mg of NES. Based on a 10% absorption rate, 450 µg/d, 300 µg/d and 150 µg/d will be absorbed respectively. The doses of Estradiol will also be tailored to the 3 formulations.

123

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Woman is between 18 and 40 years of age
  • Has intact uterus and ovaries
  • Has regular menstrual cycles of 25-35 days duration
  • Able to comply with the protocol, including frequent blood sampling, and lives within the catchment area of the clinic
  • Understands the study procedures and agrees to participate in the study by giving written informed consent
  • Able to use non-hormonal, double-barrier contraceptives (e.g. condoms and diaphragm) with every act of intercourse, or has been sterilized with tubal ligation, or only male partner has been sterilized with vasectomy
  • Progesterone \>10 nmol/L in at least one sample in the lead-in cycle

You may not qualify if:

  • All contraindications to OC use including
  • Thrombophlebitis or thromboembolic disorders
  • Past history of deep vein thrombophlebitis or thromboembolic disorders
  • Past or current cerebrovascular or coronary artery disease
  • Known or suspected carcinoma of the breast
  • Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
  • Undiagnosed abnormal genital bleeding
  • Cholestatic jaundice of pregnancy or jaundice with prior pill use
  • Hepatic adenomas or carcinomas
  • Woman has a history of headaches with focal neurological symptoms
  • Known or suspected pregnancy
  • Aged \>35 and smoker
  • BMI \>29
  • Positive urine pregnancy test at the screening or baseline visit
  • Desired pregnancy within the duration of the study
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Women's and Children's Hospital; LA County/USC Medical Center

Los Angeles, California, 90033, United States

Location

Instituto Chileno de Medicina Reproductiva

Santiago, Chile

Location

Profamilia

Santo Domingo, Dominican Republic

Location

Related Publications (1)

  • Brache V, Merkatz R, Kumar N, Jesam C, Sussman H, Hoskin E, Roberts K, Alami M, Taylor D, Jorge A, Croxatto H, Lorange E, Mishell DR, Sitruk-Ware R. A dose-finding, cross-over study to evaluate the effect of a Nestorone(R)/Estradiol transdermal gel delivery on ovulation suppression in normal ovulating women. Contraception. 2015 Oct;92(4):289-97. doi: 10.1016/j.contraception.2015.05.011. Epub 2015 May 29.

    PMID: 26032952DERIVED

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2008

First Posted

November 24, 2008

Study Start

November 1, 2008

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 17, 2015

Record last verified: 2015-04

Locations

DO(1)US(1)CL(1)